Oracle Closes goBalto Acquisition; Invests In Study Startup R&D
Clinical Research News: Study startup is generally "white space" within the clinical trials solution landscape, said Steve Rosenberg, SVP and GM of Oracle Health Sciences. "We have a CTMS product, obviously, and with the CTMS you could record some activities, but what we didn't have—and what the market doesn't really have out there—was all the workflows and processes to do proper site selection and also all the workflow to actually get all the documents completed and all the steps completed to actually get a site activated. That's a gap in our platform, and now it's been filled by goBalto."
Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Drug Development & Delivery: There is a dazzling array of quality initiatives within the clinical trials sector all looking to move the needle from paper-based methods or single-point solutions to a more integrated, non-siloed approach to study conduct. Emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall. Specifically, as a complex multi-step process, it is renowned for bottlenecks that cause a seemingly intractable 8-month timeframe for moving from pre-visit through site initiation. Improving this bleak performance is important because study startup generates more than 40% of the artifacts that eventually flow into the trial master file (TMF).
Bringing Predictability and Optimization to the Contracting and Budgeting Process
SCRS InSite:: For years, contract execution has ranked as the most time-consuming of study startup activities, in a recent survey, 50.5% of sponsors and 54.3% of CROs, cite it as the main culprit in site activation failure. With the pharmaceutical industry's intense focus on better performance, stakeholders are ready to embrace strategies that identify and help shorten long contract cycle times.
Analytics and Metrics Help Pinpoint Costs of Study Startup
Applied Clinical Trials:: The clinical trials sector has done a good job tracking costs associated with study execution, but costs linked to study startup are conspicuously absent. A quick look at industry research confirms this gaping hole in cost accountability.
Study Startup Technology Investment Pays Off
Clinical Leader:: For companies conducting clinical trials, study startup remains a major hurdle. Over the past 10 years complex protocols, difficulty in finding patients who meet inclusion and exclusion criteria, protocol amendments, and competition for sites have impacted the startup process. As a result, the activities associated with startup, including site identification, feasibility assessment, and budgets and contracting have become a priority improvement area for pharma.
A new report from Industry Standard Research (ISR) titled, eClinical Technology Adoption and Challenges in Study Startup, shines a light on the issues surrounding startup and how eClinical technologies are helping companies overcome these challenges.
More Collaboration with Investigative Sites - Less Technology Overload Delivers Transparency and Efficiency
SCRS InSite:: Years of lamenting the inefficiencies of paper-driven clinical trials have led to a stunning revolution - the sector is now awash in technology, but it is not at all clear if this is a positive development. Investigate sites are being inundated with technologies, most of which do not communicate with each other, and despite the onslaught of new technologies, there is litte evidence that they are helping sponsors and contract research organizations (CROs) collaborate with sites or enabling them to become more competitive through improved clinical trial performance.
Engagement and Adherence: How Technology is Keeping Trial Patients in the Loop
ClinPlus:: Engagement goes beyond response rates and adherence. It means zeroing in on patient experience. As PwC's Matt Rich, TimPantello and Brian Slizgi write, "In order to successfully execute clinical trials, pharma companies must amplify their focus on the patient experience and aim to incorporate the patient voice."
International Clinical Trials:: Workflow-based technology coupled with executive authoritative power, encourages process optimisation in the clinical trial continuum, helping to break down silos, enhance operational performance, and ensure quality in the electronic trial master file.
The Treacherous Study Startup Journey
Clinical Leader:: As the industry focuses their efforts to improve study startup stakeholders are reaching out to providers well-versed in the intricacies of study startup, who focus their efforts on it exclusively, and have a proven track record. This emphasis allows for the development of 'best-in-breed' solutions that not only have extensive country-specific regulatory workflows but also integrate with other eClinical solutions in the study continuum via public APIs. It's not just about speeding up the process; study startup underpins the very foundation of the clinical research value chain, ensuring downstream quality with enhanced data integrity and audit-ready regulatory compliance.
Disassembling Endemic Silos In Pharma Pivotal To Improving The Clinical Trial Continuum
Clinical Leader:: Technology provides more than just an opportunity to automate processes but an opportunity to rethink the inefficiencies of silos. Some stakeholders want to move away from vertical silos and "think horizontally." This method uses automation and workflows to integrate operational data across all functions, making it easier to extract meaningful insights from those data, and more importantly to offer significant reductions in overall study cycle times.
You Can't Manage What You Don't Measure
The Avoca Group:: There are numerous steps involved in starting clinical trials, and without risk management planning, each has potential for causing delays, and ultimately, jeopardizing the study. To mitigate this situation, technology providing risk management capabilities is a critical improvement over Excel, the incumbent tool used to track study initiation processes. A major shortcoming of Excel is its lack of project- and risk-management functionality.
Blockchain: The Next Big Disruptor in Clinical Trials?
Pharmaceutical Engineering:: The digital revolution is driving change across all industries. With its ability to increase transparency and trust between parties, the recent innovation called blockchain has the potential to significantly disrupt the clinical trials industry.
goBalto: Enabling Passion and Strategy to Drive Dramatic Growth
Insights Success:: There have been great strides in technology implementation in the conduct of clinical trials, but product development is still constrained by stubborn bottlenecks often linked to study startup (activities that occur before a study begins). The continual reliance on spreadsheets, multiple databases and unsecured emails without audit trial is inadequate to manage study startup activities. From a management perspective, the high degree of complexity results in valuable time being wasted—trying to find data buried in documents along with subsequent analyses that are notreadily available. In this environment, a multitude of status meetings to understand the results and key metrics driving startup performance is routine.
Strategies for Success with Comparator Clinical Trials
PharmaPhorum:: So why undertake comparator studies? The most common reason that sponsors use a comparator drug rather than a placebo is often an ethical one. Participants in many clinical trials are suffering from life-threatening illnesses and have enlisted in a study in order to gain access to effective treatment. It would be unethical to give no treatment at all. Ethical issues aside, the current climate is driving an increase in comparator studies, with the FDA often promoting them over placebo-controlled trials in order to avoid approving drugs that have less efficacy or pose higher risks than existing drugs
Dismantling Silos by Embracing Business Intelligence
Pharma Tech Outlook:: An end-to-end solution with workflows that aggregate data from disparate sources can identify the documents needed to conform to downstream regulatory requirements and can also signal bottlenecks or breakdowns in study execution. This approach helps to avoid rework, delays, and cost overruns; improves cycle times; and facilitates audit readiness. This approach can break down silos that have long performed in isolation with little understanding of what the next department needs to fulfill its regulatory obligations and achieve targets measured by performance metrics.
Improvements to Study Startup Underway
CenterWatch:: Sponsors and CROs have widely adopted technologies to manage ongoing clinical trials as part of efforts to improve efficiency and performance in the conduct of clinical trials, yet purpose-built tools for improving study startup have been largely overlooked. Organizations have primarily managed study startup activities with spreadsheets, internally developed solutions, modified clinical trial management systems (CTMS) or various standalone technologies. For site identification, a critical step in study startup, studies have found that sponsors have traditionally relied on low-tech approaches that are non-evidence based.
Proactive Planning is Key to Process and Quality Improvements in Clinical Trials
The Avoca Group:: Proactive planning requires sponsors and contract research organizations (CROs) to identify the risks up front, as well as the study requirements, prior to study activation. Failure to do so results in problems not being identified until much later, often in advance of an inspection and well after completed documents, artifacts and metadata have already been released to the trial master file (TMF).
Inconsistencies Prevalent in Study Start-Up
Drug Development & Delivery:: As stakeholders are increasingly aware that better study startup (encompassing the activities associated with site identification, feasibility assessment, selection, and activation) processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction.
A Force for Change: Millennials
MasterControl GxP Lifeline:: Millennials have an affinity for technology and for challenging the status quo, but what is the current and expected impact of this demographic on clinical research? And equally as important, what should sponsors and Contract Research Organizations (CROs) be doing about it?
Early Adoption of New Technology in Study Startup – When is the Right Time?
PSI on Point:: The longer a firm is successful, the more complacent and vulnerable it becomes, and the more likely it is stuck preserving and protecting what it did in the past. This proves to be a significant issue for companies when it comes to the development of new technologies in today's world. If companies rest on their laurels, they may be eclipsed by early adopters of technology and struggle to regain market share in the future. If companies adopt too soon, they wind up investing significant capital and efforts in an immature and unusable solution. The question then becomes: when is the right time to adopt a new technology?
Passion And Vision Forge A New Path For Drug Development
Forbes:: Study startup is the foundation and starting point of clinical trials. Too often, if a study is improperly started, it requires "rescue," which is the costly practice of adding more investigative sites to complete enrollment targets. This is a big challenge as an estimated 80% of clinical trials fail to meet enrollment timelines. This degree of inefficiency leads to a 94% rise in study timelines. Given this tough scenario, it's time for innovators who understand the business of clinical trials and have a passion for change to step forward and bring new innovations to the table.
Millennials and their Impact on Clinical Research
Applied Clinical Trials:: Millennials have impacted the evolution of technology and are used to instant and mobile communication. As a result, they are often skeptical of legacy entrenched systems that are inefficient, cumbersome, and lacking in transparent communication mechanisms. This has important implications for both research teams as well as patients.
When It Comes To Study Start-Up, The News Is Still Bad
Clinical Leader:: According to data from Tufts Center for the Study of Drug Development, in 2005 there were 6,465 drugs under development globally. By 2015, that number had soared to 10,686. Unfortunately, during that time other metrics that could be used to measure the success of pharma R&D efforts moved in the wrong direction.
Tufts: CROs investing more in tech, beating sponsors on site-related timelines
Outsourcing-Pharma:: Technology investments are catalyzing the study starty-up process - and with more investment coming in from CROs, sponsors complete all site-related activity 6 to 11 weeks slower, according to a recent Tufts report.
Molasses in Study Startup Efficiencies
Applied Clinical Trials:: Over the past decade study startup, encompassing the activities associated with site identification, feasibility assessment, selection, and activation, has become a priority improvement area in the conduct of clinical trials. Numerous factors can adversely impact study startup and its efficiency, in an industry plagued by rising development costs and increasing complexities.
Distributed Ledgers Can Streamline Clinical Trials
Distributed & NASDAQ.com:: In "Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process," a 2014 book edited by Peter Schueler and Brendan Buckley, experts describe how the pharmaceutical industry is currently operating under a business model that is not sustainable for the future.
Are Clinical Research Sites a Dying Paradigm?
MasterControl GxP Lifeline:: Patient recruitment and retention are additional challenges for investigative sites that drive up overall costs. Some estimates have indicated that patient recruitment is responsible for 30% of the time it takes to conduct a clinical trial, and sadly, a significant number of sites never enroll a single patient.
Blockchain Technologies Poised To Disrupt Stagnant Trial Timelines
Forbes:: The enormous amounts of data generated in clinical trials, along with trends towards globalization and increasing regulatory constraints, is outstripping the ability of legacy data management platforms to manage the competing needs of data sharing, patient privacy and data integrity. Reproducibility, regulatory approval, data integrity, data sharing, personal data privacy concerns and patient enrollment are significant challenges for modern clinical trials. How could blockchain technologies help?
Automated Site Payments: Key To Successful Engagement
Clinical Leader:: Many sites struggle financially under the burden of a rapidly changing clinical ecosystem. Sites are responsible for much of the non-patient-facing tasks that are necessary for running a clinical trial — finding clinical trials of interest, completing feasibility studies, satisfying regulatory requirements, good clinical practice (GCP) training, negotiating contracts, documentation, data entry, learning and integrating technology solutions mandated by the sponsor or CRO, and more.
Tufts CSDD Survey Finds Study Startup Cycles Remain Inefficient for New Sites
CenterWatch:: Companies reported 28 percent longer clinical trial cycle times and startup processes for new sites compared to repeat sites, according to a study conducted by the Tufts Center for the Study for Drug Development (Tufts CSDD) and goBalto.
Clinical trials: collaboration is the secret to successful outsourcing
PharmaPhorum:: Bringing new products to market in the era of outsourced clinical trials is reliant on the ability of sponsors and CROs to work together. The increasing globalisation of R&D has led to a rise in clinical outsourcing, as pharmaceutical companies find it difficult to operate solely with in-house teams.
Wide inconsistency observed among clinical trials' startup time: Tufts report
FierceBiotech:: Clinical trials on average take about six months to go from site identification to study startup, but there are wide differences between using new sites versus repeat sites and between CROs and biopharma companies, a new report by the Tufts Center for the Study of Drug Development discovered.
Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations
Therapeutic Innovation and Regulatory Science:: During the past decade, site identification, site selection, and study start-up have become priority improvement areas in the conduct of clinical trials. Numerous factors can adversely affect study start-up speed and efficiency. Protocols that are both scientifically and operationally complex, for example, are associated with poor recruitment and retention rates.
Why Are Metrics Important in Starting Clinical Trials?
Drug Development & Delivery:: This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays. According to a recent study by KPMG, within the pharmaceutical industry, the return on R&D expenditure has fallen from an industry average of approximately 20% 20 years ago, to 10% now, with the average cost of developing a drug rising during that period at a rate 7.4% higher than inflation, with the increasing costs of conducting clinical trials responsible for most of this increase.
Improving SSU and the Clinical Trial Continuum
Pharmaceutical Engineering:: Workflow-based technology in the clinical trial continuum encourages process optimization, helps break down silos, enhances performance quality, and has a measurable effect on the electronic trial master file.
Dismantling silos key to improving the clinical trial continuum
CenterWatch:: While technology remains critical, as emphasis shifts to process optimization it may be only part of the solution. Point solutions can hinder the flow of data across the continuum, causing already entrenched silos to dig in further. To improve performance quality in study startup, two factors are needed: an end-to-end solution and support from top management.
Is Automation In Clinical Trials A Panacea?
Forbes:: The entire healthcare industry is working to reduce the staggering amount of money the country spends on healthcare every year. Reducing prescription drug costs is critical to that effort. Introducing automated workflows to eliminate repetitive, manually intensive processes will simplify data gathering and analysis, improve communications and productivity levels and facilitate accurate tracking and reporting on process steps and completion dates. Yet automation is just the first step to making significant, lasting improvements in study execution.
The Antagonistic Innovators In Clinical Research: Millennials
Forbes:: "The purpose-driven generation" is how millennials are often characterized, constantly seeking affirmation in what they do. It is this inherent desire for self-determination and self-worth that makes this group the antithetical innovators that the clinical trials industry so desperately needs, having long demonstrated an affinity for technology, which has led to transformative changes in other industries.
CRO Consolidations: A Boon for Pharma?
Contract Pharma:: Outsourcing has become a popular way for pharmaceutical companies to utilize on-demand services to improve operational efficiency and therapeutic expertise, cut costs, and add more extensive geographic capabilities. As demand for their services has intensified, the CRO industry has responded with a growing movement towards consolidation in order to expand capabilities and reach to service large global studies.
Accelerating trials from the outset
CenterWatch:: Research from the Tufts Center for the Study of Drug Development (CSDD) indicates that starting clinical trials from site identification through to activation is highly inefficient, with cycle times that have not budged in over two decades. Not surprisingly, study startup (SSU) has been receiving renewed focus from pharmaceutical companies under intense pressure to reduce timelines and abate the rising costs of drug development.
The Gold Rush and Monopoly Land grab in eClinical growth
CenterWatch:: In 2015, the global eClinical software market was forecasted to reach $6.8 billion by 2020. Recent research now doubles that estimate by 2024. The global increase in clinical trials is driving this growth, as the industry evolves from its slow paper-based methods and standalone spreadsheets toward automated, cloud-based systems to confront the oft-mentioned costs of drug development.
Risk Mitigation in Clinical Research: It Starts with Study Startup
MasterControl GxP Lifeline:: For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays.
The Emergence of the Few: M&A in the CRO Industry
Applied Clinical Trials:: In response to intense competition and the need to offer a comprehensive portfolio of service offerings, the CRO industry has been undergoing significant consolidation in recent years.
Top 25 Biotechnology Solution Providers 2017
CIO Applications:: Throughout history there have been disruptive technologies that have altered the current course of technological evolution. Biotechnology and biomedicine companies by nature, experience explosive growth, as scientific innovation feeds and fills their markets with novel products and services.
International Clinical Trials:: Since the international committee of medical journal editors established trial registration requirements in 2005, enrolment has increased fivefold. In the US alone, clinical trial registration has increased tenfold during this same time period, but, against this backdrop, the EU recorded a concerning 25% decrease in clinical trial applications (CTA) from 2007 to 2011. Why?
CRO Consolidation: A Sinister Threat Or Windfall For Pharma?
Forbes:: Outsourcing has become the popular way for pharmaceutical companies to utilize on-demand services, improving operational efficiencies and therapeutic expertise and adding extensive geographic capabilities. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.
Clinical Research and the Challenge for Rare Diseases
PM360:: Last year, I was unexpectedly thrust into the world of rare diseases. My sister, Annie, was diagnosed with Pseudomyxoma peritonei (PMP), a rare type of appendix cancer. Given PMP's rarity, Annie's doctor was less than optimistic about the prognosis. But there was a glimmer of good news: A pioneering surgical procedure recently had been developed. The bad news, however, was that the procedure was only available at two centers in the country and, even if Annie was accepted, it would be considered a last resort, with inconsistent reports of success.
Are Site-Less Trials the Future of Clinical Research?
Pharmaceutical Processing:: The site-less model allows patients to accomplish study visits from the comfort of their own homes, while effectively eliminating the need for site selection and activation activities on multiple sites. In the process, study sponsors save significant amounts of time and money, while dramatically reducing trial participation burden on patients.
The antithetic Millennial and their impact on innovation detractors
CenterWatch:: By 2025, Millennials will make up the majority of the workforce. In response, companies are clamoring to understand how to recruit, motivate and retain these workers. But what is the current and expected impact of this demographic on clinical research?
Software-Enabled Clinical Trials
Medium:: Today, only 5% of the US population participates in clinical research. With the rise of new software tools that make research faster, cheaper, and more accessible and with a forward-looking FDA digital health team, the time is ripe for a clinical trial paradigm shift. Regarding site launch and training, goBalto is building an end-to-end study startup platform that speeds clinical trials through site selection, feasibility, and activation. The team is shifting the time to set up a site from months to weeks or days.
Site Selection a Continuing Conundrum
CenterWatch:: For many companies, searching for clinical trial sites begins with a look at paper-based and spreadsheet tools that document where they had held earlier trials. Returning to familiar sites allows clinical trial teams to work with principal investigators with whom they have built relationships over time. On the surface, this approach makes sense. But in reality, it is time-consuming, inefficient and may not result in the best sites for a given study.
Disrupting Clinical Operations With CRO Strategic Partnerships
Clinical Informatics News:: In response to tighter margins, globalization and increasing regulatory complexity, sponsors have been embracing an outsourcing model using Contract Research Organizations (CROs) to conduct scientific services for all phases of clinical research. A primary motivator driving this trend is the expected benefits to be gained from external specialization, allowing drug makers to focus on core competencies and a value-focused workflow.
Are Clinical Research Sites a Dying Paradigm?
Drug Discovery & Development:: A recent analysis by the Manhattan Institute determined that Phase III clinical trials account for 90% or more of the cost of developing an approved drug from laboratory to pharmacy. Given that reliable estimates put the cost of developing, and gaining marketing approval for a new drug, at well over a billion dollars, it's clear that human trials are pivotal to the pharmaceutical industry scrambling to find ways to reduce costs and speed timelines, while maintaining the quality and efficacy of the research.
How CROs Are Helping With Healthcare's Data Problem
Forbes:: As the debate over reforming the nation's healthcare system rages on, there's at least one goal all sides can agree on: bring costs down. According to data the Centers on Medicare and Medicaid Services released in December, Americans collectively spent $3.2 trillion on healthcare in 2015.
Upfront planning crucial to process improvements and quality in clinical trials
CenterWatch:: If you fail to plan, you are planning to fail. These words ring true when it comes to study startup (SSU), especially as the clinical trials sector embraces planning as key to boosting study quality. With research showing a continually stagnating timeframe for conducting clinical trials and a trend toward overhauling study performance, quality improvement is moving to center stage.
Are delays in clinical trials due to a lack of experienced CRAs
CR pro:: In an industry plagued by rising development costs and increasing complexities, to what extent is the CRA shortage to blame for the delays in clinical trials? It is fair to say that it is a contributing factor, but it is equally important to point out that well documented bottlenecks in starting clinical trials, such as, protocol amendments, contract and budget negotiations, IRB approvals, and others, contribute to significant trial delays and these are not the primary responsibility of the CRA.
DevOps shops weather growing pains with infrastructure-as-code tools
TechTarget:: Sys admins look to infrastructure-as-code tools, such as CloudFormation and Terraform, to keep up with rapidly changing infrastructure, but those tools are also evolving.
Technology Solutions for Investigative Sites – Are They Just a Burden?
Bioscience Technology:: Digital technologies are revolutionizing the ways in which we communicate with each other, impacting all aspects of modern life, including the ways in which clinical research is being conducted. Increasingly under pressure to reduce study timelines and costs, the pharmaceutical industry has been deploying eClinical solutions to reduce the inefficiencies in trials resulting from complicated protocols, globalization, and paper-based methods—with improved communication and collaboration between teams an essential component of these technologies.
Rising demand for CRAs
CenterWatch:: Demand for Clinical Research Associates (CRAs), professionals whose main function is to monitor clinical trials, is expected to grow 1.52% annually by 2018, which results in many sponsors and CROs finding themselves in a never-ending recruitment cycle for qualified CRAs.
Here's how we can fix the chronic principal investigator shortage
MedCity News:: While efforts to attract and train new investigators are certainly important, they do not address the root cause of the experienced investigator shortage.
The perils of building clinical trials on a shaky foundation
BioPharma DIVE:: With spiraling costs and increasing stakeholder demands, it is critical that studies get off to the right start, in terms of patient selection and recruitment. This is self-evident for pharmaceutical companies needing to remain competitive, allowing them to scale the number of new drug candidates in their pipeline — particularly for complex therapeutic areas such as oncology and central nervous system. But how do we get there?
Why Is Study Start-Up Still So Inefficient?
Clinical Leader:: The Tufts Center recently completed a study on the clinical trial start-up process, which solicited responses from more than 300 individuals at pharma companies and CROs. This was actually a follow-up study to one that was conducted in 2009. That study specifically looked at the site initiation process, examining the timeframe necessary to complete certain activities. The survey found wide variation between companies, indicating that company practices are highly inconsistent.
Myopic Focus on Dashboards may Blur Insights
PharmaVOICE:: When utilizing operational metrics, dashboards capture and display metrics associated with an increasingly smaller slice of time/artifact activity, which is critical when reviewing processes for optimization and to providing an organization with a competitive edge, the risk posed, however, is that detailed and elaborate dashboards may lead to suboptimal decisions being made due to information overload.
Patient-led trials: A formula for success
PharmaPhorum:: Today patients are taking more responsibility for their own care as they search the massive amount of data available on the internet. New technologies have helped them to become more connected and empowered and generate and share data. Recognising the opportunity to engage with highly motivated patients and/or patient organisations, to both reduce cost and improve success in clinical trials, pharma companies are beginning to explore the concepts of patient-centric and patient-led trials (PLCTs).
Building Quality into Study Startup (SSU)
Applied Clinical Trials:: Benjamin Franklin is often credited with this wise warning: If you fail to plan, you are planning to fail. When it comes to study startup (SSU), and site activation in particular, these words ring true, especially as the clinical trials sector embraces planning as key to boosting study quality. With the availability of workflow-based SSU tools, proactive planning is within reach for stakeholders who view this function as pivotal to improving quality, as measured by audit-readiness and the likelihood of passing regulatory audits.
The Illusion of Safety in Study Startup
CenterWatch:: Risk is our constant companion, and as clinical trials grow in complexity, so do risk-based challenges to bring new therapies to market at an ever-increasing pace. The continued reliance on Excel, which lacks project- and risk-management functionality, has created an illusion of safety often fueling the rescue study industry.
How Effective Are Study Startup Regulations?
Clinical Informatics News:: The clinical trials sector is highly regulated, and justifiably so. Biopharmaceuticals that patients need and depend on must be safe and effective, which is why international regulations for Good Clinical Practice and an array of regulatory guidances focus on how clinical trials should be conducted. But study startup (SSU), one of the most complicated and challenging parts of the clinical trials process, has surprisingly few guidelines. With limited regulations focused on this early part of clinical trial execution, what does it mean to be compliant?
10 Criteria to Aid in the Selection of Investigative Sites
MasterControl GxP Lifeline:: Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.
Is clinical trial design complexity behind the high turnover rate for principal investigators?
MedCity News:: "I can make more generals, but horses cost money" — Abraham Lincoln. Principal Investigators (PI) may not be the generals Lincoln had in mind when he made this statement, nevertheless they are one of the key players in the clinical trial efficiency equation. They are ultimately responsible for the conduct of the trial at the investigative site. Achieving operational efficiencies at investigative sites is key in the efforts to control costs and ensure successful clinical trials. Unfortunately, the pharmaceutical industry is experiencing a shortage of experienced PIs.
The Vanguard of Patient Centricity: Patient-Led Clinical Trials
Clinical Leader:: Amid the AIDS epidemic during the late 80's, Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, found himself at a crossroads. As a long-time proponent of the traditional "research to approval" drug development model, involving randomized clinical trials and lengthy regulatory reviews, Fauci was faced with the realization that this traditional approach would be of little benefit to AIDS patients without the luxury of time. Something had to be done. But what?
Improving Minorities' Participation In Drug Trials Can Help Reverse Rising Healthcare Costs
Forbes:: The road from the development of a new drug in a laboratory to shepherding it through a series of clinical trials and presenting research findings to the Federal Drug Administration (FDA) is a long and expensive one. The costs range from $100 million to several billions of dollars, and the entire process can drag on for more than a decade. Adding to that stress is the fact that all this money and time is spent at great risk to the drug companies and its investors. We work with several of the world's top pharmaceutical companies and Contract Research Organizations (CRO), and I can tell you this: there is no industry with more on the line. A product can fail at any point during the testing process, and everything invested up to that point is lost forever.
Why the cloud is pivotal to speeding clinical trials
CenterWatch:: Clinical trials are growing in complexity, complicated further by the convolution of demand, outsourcing and globalization. According to a recent study by KPMG, within the pharmaceutical industry the return on R&D expenditure has fallen from an industry average of approximately 20% in the late 1990s to just 10% today, while the average cost of developing a drug has risen during that period at a rate of 7.4% higher than inflation, due largely to the cost of conducting clinical trials.
It's Time to Revamp the Unsexy Plumbing of Clinical Trials
Drug Development & Delivery:: There is no doubt that clinical research is critical to the advancement of medicine and public health. But conducting such research is a complex, resource-intensive endeavor that relies on a multitude of stakeholders, workflows, processes, and information systems. Clinical trials play an essential role in the drug development process by effectively demonstrating the efficacy and safety of a pharmaceutical compound – but they are not for the faint of heart, conducting even one is a monumental task with complex processes and issues that can surface and derail a study's timeline.
Are Local IRBs Really Necessary?
Insite, The Global Journal for Clinical Research Sites:: Many researchers have complained that use of different local IRBs to review each research site for a multicenter trial is extremely inefficient and leads to additional cost burdens and trial delays. In a survey conducted by the Federal Demonstration Partnership (FDP) in 2012, principal investigators on federal grants reported that they spend about 42% of their time on "administrative burden," with IRB-related burdens ranking highest. Despite this, many US research sites have been hesitant to use a single, centrak IRB.
Myopic Focus on Dashboards May Blur Insights
Bioscience Technology:: When utilizing operational metrics, dashboards capture and display metrics associated with an increasingly smaller slice of time/artifact activity, which is critical when reviewing processes for optimization and to providing an organization with a competitive edge. The risk posed, however, is that detailed and elaborate dashboards may lead to suboptimal decisions being made due to information overload.
The Data Driven Reality of Clinical Trials
MasterControl GxP Lifeline:: Why are metrics important in starting clinical trials? This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays.
To improve drug development, it's time to rethink clinical trial site engagement
MedCity News:: For clinical development teams, there are many parallel and competing factors to consider when preparing for and conducting clinical trials. From finalizing the study protocol to ethical/regulatory reviews to coordinating drug product supply, there are multiple overlapping activities across different partners in the clinical trial ecosystem.
Alternative Fact: Site Identification Is Not Critical To Clinical Trial Efficiency
Life Science Leader:: On the surface this may seem to have some validity, as sponsors and CROs often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data. Moreover, the practice of adding more sites per study than necessary and requiring each site to recruit fewer subjects per site is a standard, although questionable, risk mitigation practice. So how important can site identification be to the efficiency of clinical trials?
goBalto: Simplifying the Clinical Study Startup Process
CIOReview:: Historically, the clinical trial process has been marked by high expenditure, time consuming often manual processes and over-reliance on archaic technology. Around $150 billion is spent annually by pharmaceutical companies on trials, with only 1 in 10 drugs ultimately obtaining regulatory approval.
10 Tips for Selecting High Performing Clinical Sites
Bioscience Technology:: Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of clinical trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in the range of $1M to $8M due to delayed market entry.
Overcoming the Innovation Malaise
CenterWatch:: Innovation is often cited as the "key ingredient" by organizations striving to sustain an advantage in the increasingly competitive global marketplace. The pace of technology change is relentless, with those who don't embrace emerging trends often paying a hefty price. Simply "doing the same thing better," however, is not enough.
How Many Team Members Does It Take To Determine The Study Status?
Clinical Leader:: Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: "How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?" I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.
Out of Control
International Clinical Trials:: Epidemics like the Ebola virus in 2013 are extremely hard to contain. With the clinical trial process often taking many years to obtain authorisation, new and innovative designs need to be explored to ensure that vaccines can be approved as soon as possible.
Modeling and Simulation in Clinical Trials: Real Potential or Hype?
Applied Clinical Trials:: Improving experimental drug success rate and accelerating clinical development are top priorities for pharmaceutical companies. Careful decision making during drug development is essential to minimize development time, manage costs and improve the probability of commercial success. Recently, many of the major pharmaceutical companies have begun to explore computer-based bio-simulation strategies to help generate the information necessary to make better decisions.
Director of Life Sciences Recaps SCOPE 2017
DRI Direct Recruiters Inc:: Aptly named after the legendary Husky (who coincidentally now resides in my hometown), goBalto's mission is to get medicine to patients in need faster by accelerating the time-to-market for new drugs, medical devices, and other therapies. Their SaaS applications offer an end-to-end solution for starting Clinical trials.
How Patients Will Revolutionize Next-Generation Clinical Research
Life Science Leader:: Often when we think about inefficiencies in the clinical trial process, we focus on the role of the sponsor or CRO, a particular aspect of the value chain, or new technologies that promote data sharing and faster decision making. While these are critical aspects that drive day-to-day operations, there is another aspect of the value chain that we may be neglecting: the patient side.
First Mover Does Not Always a Market Leader Make
Medium:: No matter your industry, you likely feel intense pressure to get your product or service to market before your competitors. But if that's the first lesson in the Business 101 curriculum, the second should be that achieving "first-mover" status never guarantees success. How can you walk the line between getting to market quickly, but not too quickly? To borrow from Sun Tzu, "If you know the enemy and know yourself, you need not fear the result of a hundred battles."
Will Special Interests Derail The Future Of Personalized Medicine?
Clinical Leader:: The increasing need for personalized medicine, and resulting demand for companion diagnostics, has led to the integration of the previously separate activities of drug and diagnostic development. The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is upon us.
Are Clinical Trial Matching Services Truly Patient-Centric?
Applied Clinical Trials:: If you have ever tried to find the right clinical trial for yourself or a loved one, you know the process can be confusing and challenging. Recognizing the need for alignment, several so-called clinical trial to patient matching services have emerged. Though well-intentioned, some of the current formats adopted by these service providers may inadvertently be introducing additional complexity into the lives of patients looking for life saving therapies.
To you it's a document; to me it's my life
PharmaPhorum:: Proactive and included patients can help clinical trial retention as well as providing more accurate results. Jae Chung relates the story of one cancer patient who took the initiative to ensure his treatment went ahead.
Using Real World Data to Enhance Clinical Trials
Clinical Informatics News:: Randomized clinical trials (RCT) remain the trusted standard for assessing pharmaceutical drug and medical device safety and efficacy. An RCT uses a carefully planned experimental framework to compare an intervention/treatment with a control, investigating the effect of each treatment option on a defined outcome. Patients participating in an RCT are carefully screened based on precise clinical criteria, and usually have very similar characteristics. Unfortunately, life does not always mirror the idealized world of an RCT.
Moving Beyond Clinical and Operational Metrics in Study Startup
CenterWatch:: Metrics are central to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages. They also drive competitive performance among those organizations performing trials.
Drug Discovery & Development's Top 7 Stories of 2016
Drug Discovery & Development:: Drug Discovery & Development has rounded up our most popular stories of 2016. These articles provide a snapshot of the change the pharmaceutical industry experienced throughout the year.
Top 10 of 2016
Clinical Leader:: Clinical Leader set multiple monthly website traffic records. For the year, we recorded more visits than any point since we launched five years ago. The Clinical Leader editorial board also added several passionate experts to our distinguished list of clinical professionals. Here are our Top 10 lists for 2016, organized by article type.
Accelerating Innovation to Cut Drug Prices
The Huffington Post:: Americans spend a staggering amount of money for prescription drugs, and the prices keep rising. Cases of corporate greed like the infamous Martin Shkreli, former CEO of Turing Pharmaceuticals who increased the price of the life-saving medication Daraprim by 5,000 percent, have become the public face of the entire industry. That's unfortunate because it's grossly unfair to paint all drug manufacturers with such a broad brush. However, the industry does need to take it upon itself to overhaul a research and development process hamstrung by clinical trials that drag on for years and cost billions of dollars.
Novartis Approach Slashes Study Startup Time
Clinical Leader:: If the scientific rationale seems rather complicated, then the trial may need a scientific review committee in addition to the IRB. Each one of those reviews could take a month or more. Petrone notes goBalto has a solution that can make cycle-time transparent. While the solution may not change cycle-times, it will allow companies to see what processes are taking the longest. With that insight, sponsors can start to examine what can be done to shorten them.
Why is there such Inefficiency in Site Selection?
CenterWatch:: This question is often asked about an industry deeply rooted in paper-based, spreadsheet tools for clinical trial conduct. Study teams have continued to rely on these older tools and relationships with principal investigators that have developed over time to select sites, building an institutional knowledge about specific sites based on previous studies.
Barriers to Increased Participation of Minorities in Clinical Trials
Pharmaceutical Outsourcing:: Clinical trials are at the heart of the process for bringing new medicines to patients. One of the most critical aspects to the conduct of any clinical trial is identifying the right group of people to include in the study. Unfortunately, many of the clinical trials conducted in the United States suffer from a lack of diversity, with minority populations being consistently underrepresented.
Could Gamification Improve Clinical Trials?
Applied Clinical Trials:: The gamification of many aspects of our culture is well under way, and some researchers are even beginning to consider the integration of gamification principles into clinical trials. In the context of clinical trials, gamification presents an excellent opportunity to improve performance and reduce costs.
Are Delays in Clinical Trials Due to a Lack of Experienced CRAs?
Drug Discovery & Development:: In an industry plagued by rising development costs and increasing complexities, to what extent is the CRA shortage to blame for the delays in clinical trials? It is fair to say that it is a contributing factor, but it is equally important to point out that well documented bottlenecks in starting clinical trials, such as, protocol amendments, contract and budget negotiations, IRB approvals, and others, contribute to significant trial delays and these are not the primary responsibility of the CRA.
10 Tips for Enabling Better CRO-Sponsor Collaborations
MasterControl GXP Lifeline:: By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship.
Contract Pharma:: The reality is that the sponsor-CRO relationship is not always a win-win. While sponsors are clearly enticed by the efficiencies that can be gained through CRO use — a recent report from ISR projects that the CRO industry will grow at a rate of 7.4% CAGR through 2019 - there is nonetheless a downside to the relationship.
Fighting the Commoditization of Sites: It Starts with the Site Initiation Visit
Bioscience Technology:: One of the biggest factors contributing to lengthy cycle times is the inability of sponsors and Contract Research Organizations (CROs) to engage investigative sites in a manner that supports effective patient recruitment and retention in the context of a swift budget and contract process. In this mentality, the site is treated less like a valued partner and more like a commodity in the clinical research lifecycle. Want to move towards better engagement models? It starts with the Site Initiation Visit (SIV), a critical event that sets the stage for an open, collaborative relationship to last throughout the study.
Eliminating the Three Evil "E's" in Starting Clinical Trials
Applied Clinical Trials:: In an effort to confront the oft-mentioned costs of drug development, the clinical trials industry has been evolving from its slow paper-based methods and standalone spreadsheets towards automated, cloud-based systems. There has always been a strong focus on study conduct and quality. But as stakeholders are increasingly aware that better study startup (SSU) processes are linked to shorter clinical timelines, the emphasis is shifting in that direction.
Managing Clinical Trial Complexity
Advance for Health Information Professionals:: While most of the industry's risk management efforts have focused on post-marketing drug safety, the clinical trial process holds a broad array of other potential risks that could jeopardize a company's multi-million-dollar product development investment-risks such as site staffing shortages, patient recruitment issues, logistical problems with drug supplies, or regulatory delays. Risk management in clinical operations really starts with effective project management.
PSI selects goBalto's site ID cloud-based software to speed up trials
Outsourcing-Pharma.com:: The Swiss contract research organization (CRO) has chosen goBalto's end-to-end solution to assist with site identification, feasibility assessment and selection for sites for the study.
The Struggle To Speed Study Start-up
Clinical Informatics News:: Recent research conducted by Tufts Center for the Study of Drug Development (CSDD) has found that clinical research organizations (CROs) face an increasingly complex and competitive environment in which to administer clinical trials. Study start-up, in particular, can be a drawn-out process that, depending on the protocol, budget negotiations, and availability of patients, can last anywhere from a few months to a full year. CROs are therefore looking for strategies, whether in the form of tools or processes — often a combination of both — to streamline this complicated phase.
10 Tips for Enabling Better CRO-Sponsor Collaborations
CenterWatch:: By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship.
Assessing Practices & Inefficiencies with Site Selection, Study Start-Up, and Site Activation
Applied Clinical Trials:: Sponsor and contract research organization (CRO) companies conducting global clinical trials face numerous operational and logistical challenges. With more than 3,000 active global clinical trials conducted annually at approximately 40,000 investigative sites dispersed worldwide, companies are looking for more efficient ways to streamline their processes in order to speed up timelines.
Concomitant medications in clinical trials: Why the stakes are high
PharmaLive:: Almost every reported concomitant medication has a reason – and many, if not all of these reasons should be reported as adverse events. Concomitant medications (a.k.a., con-meds) are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.
Removing the Blinders in Site Selection
Advance for Health Information Professionals:: One of the most difficult aspects [of clinical trials] is the selection of the right sites by sponsors and contract research organizations (CROs), who often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data.
International Clinical Trials:: Standard operating procedures (SOPs) rarely grab the spotlight like transformational technologies or newer strategies, such as risk-based monitoring or Quality by Design. But SOPs deserve some love. With their coveted goal of improving operational efficiency, they have long been fundamental to many industries, and the clinical trials sector is no exception.
SmartViews: The unsexy plumbing of clinical trials
PharmaTimes:: There is no doubt that clinical research is critical to advancing medicine and public health. Clinical trials play an essential role in drug development by effectively demonstrating the efficacy and safety of a pharmaceutical compound, yet they are not for the faint of heart. Conducting even one is a monumental, complex and resource-intensive endeavour that relies on a multitude of stakeholders, workflows, processes and information systems.
Co-Opting Innovation: How Startups and Big Companies Together Accelerate Innovation
CIOReview:: The race to innovate is increasingly a top priority for businesses across all sectors. The fact is that only a tiny percentage of companies will prevail.
Virtual Clinical Trials: The Future of Patient Engagement?
Applied Clinical Trials:: Virtual clinical trials represent a relatively new method of collecting safety and efficacy data from clinical trial participants, from study start-up through execution to follow-up. These trials take full advantage of technologies (apps, monitoring devices, etc.) and online social engagement platforms to conduct each stage of the clinical trial from the comfort of the patients home—including recruitment, informed consent, patient counseling, through to measuring clinical endpoints and adverse reactions.
DevOps is slowly taking over the IT landscape
TechTarget:: IT teams—from 50-year-old companies migrating apps off the mainframe to stateless cloud-native DevOps adherents—are investigating infrastructure automation via Ansible.
It's Site Selection, Not a Toss of the Dice
Clinical Informatics News:: Conducting clinical trials is a high stakes game, but disturbingly, the risk of selecting non-performing or underperforming investigative sites is greater than losing at the gambling table.
Making Site Selection Precise And Accurate
Clinical Leader:: Underperforming investigative sites have long been a puzzling issue for clinical trial stakeholders. There are lots of reasons for sub-optimal performance, ranging from inadequate processes for study execution to overly complex protocols. Current thinking suggests that at least some of the problem stems from continued reliance by many sites on paper-based or simple spreadsheet methods for numerous aspects of study conduct.
Disruptive Technologies: Breaking Down Barriers to Drug Development
Applied Clinical Trials:: Many factors contribute to the increasing challenges and costs of developing medicines, including more complex disease targets, increasing regulatory requirements, larger clinical trial sizes, and greater focus on targeting chronic and degenerative diseases. Companies are exploring ways to reduce development times and increase the odds of success using new research models, adaptive clinical trial designs and methodologies, eClinical tools, innovative approaches to patient recruitment, and automated techniques for analyzing data. Still, challenges remain.
The Cloud: speeding drug delivery
DisruptiveViews:: By playing a critical role in enabling digital transformation, cloud computing lowers typical IT barriers of slow time to value, risky implementations, limited resources, heavy maintenance, and incompatible systems. Allowing cloud computing to free up resources to run the business enables organizations to focus their time and energy on the pursuit of innovation and growth.
Getz: Site Activations Hurt By Commodity Mentality
Clinical Leader:: Site activation in clinical trials is not an efficient process. Those inefficiencies delay the start of trials and are costly to sponsors, CROs, and sites. But more importantly, they keep medicines from getting to patients in a timely manner. Many of the issues are ones that investigative sites have been vocalizing for some time, but which sponsors and CROs have been slow to hear.
Breakthroughs in Clinical Trials Utilizing the Power of the Cloud
CloudTweaks:: Inefficiencies in the clinical trials process continue to stymie industry stakeholders anxious to rein in the cost of product development and adhere to tighter timelines. There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. Discontent with the 'status quo' and dismal performance metrics are driving a cacophony of infrastructural changes with stakeholders embracing technologies that are finally moving the needle.
Innovation Detractors in Pharma
Bioscience Technology:: Innovation is a critical ingredient for companies striving to sustain an advantage in the increasingly competitive global marketplace. Simply "doing the same thing better" is not enough. Across multiple industries, companies are focusing their top teams on leveraging social, mobile, analytics, and cloud to implement "disruptive" technologies designed to promote innovation and transform the enterprise. And while many industries are blazing new trails in pursuit of new technologies, pharma appears to be lagging behind, often adopting a watch and wait approach.
Addressing The Challenges Associated With Site Selection For Clinical Trials
xTalks:: Planning for and conducting a clinical trial presents many challenges associated with study design, patient safety and outcome determination. With growing pressure from stakeholders to speed the process of drug development, and increasing demand from regulators to submit compelling data, it’s easy for clinical trial coordinators to lose sight of one of the most important aspects of the process: study startup.
Refocusing on Risk Mitigation in Starting Clinical Trials
The CenterWatch Monthly:: Site selection, traditionally manually intensive, is a critical step in getting clinical trials off to a good start, yet poorly performing sites have long been a tough challenge for the industry.
'Paradigm shift needed' in trial site selection process
Outsourcing-Pharma.com:: goBalto has launched a trial site scoring system it claims will improve site selection by taking a data-driven approach. The new solution, called Select, provides sponsors and CROs with a data-driven approach to weighing selection and performance variables to aid in identifying sites and target populations ideally suited to their studies.
goBalto Optimizing Clinical Studies
CIOReview:: Pharmaceutical companies are constantly looking to innovate and perform business operations in smarter ways, as the costs of drug development have continued to escalate. It is a race against time to develop drugs that save lives and ease suffering. And while the healthcare industry has made tremendous strides, an area that remains frustratingly slow are the clinical trial.
Utilization of the Crowd for Medical Research
Bioscience Technology:: The concept of using the crowd as a resource for funds and ideas has made major inroads into modern society, being utilized in such diverse fields as journalism, law enforcement, product design, graphic design, architecture, and much more. Recently, some have begun to explore the utilization of the crowd for various purposes in medical research, including fundraising as well as crowdsourcing for intellectual analyses and insights.
PharmaTimes:: As clinical trials grow ever more complex, there are steps companies can take to keep their studies on track and on target.
Rethinking "Patient Centricity": Using Technologies to Distribute Clinical Trial Results Direct to Patient
IEEE LifeSciences:: The drug development community is increasingly turning to patient engagement or "patient centricity" approaches to optimize clinical trials costs and improve research outcomes. The active participation of patients in clinical research can potentially lead to improvements in the credibility of results, higher rates of enrollment and retention, and ultimately, lower trial costs.
Time For Business Intelligence in Study Startup
BioPortfolio:: The clinical trials sector is heavily invested in technologies that track how studies unfold, but putting that information to good use requires real-time visibility actionable data.
Better Study Startup Means Less Study Rescue
Pharmaceutical Compliance Monitor:: When a clinical trial does not unfold as planned, it may be heading for rescue. Communication problems among stakeholders, patient enrollment delays, overly complex protocols, and poor site compliance are just a few of the many reasons why rescue action is needed.
Risk Mitigation Pivotal to Starting Clinical Trials
Drug Discovery & Development:: While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks just waiting to derail a company's high-dollar development programs.
Reflections and Predictions
PharmaVOICE.com:: PharmaVOICE celebrates 15 years of trends with a look back at the market forces that have defined the industry and what's ahead as the healthcare ecosystem continues to be reinvented.
The Achilles Heel of Clinical Study Startup—Bottlenecks
Clinical Leader:: The clinical trial phase of a drug development program is by far the most costly, risky, and protracted phase of the investigative process. Over the past decade, the capitalized cost to develop an approved new drug has more than doubled to $2.6B, with the approval rate for drugs entering clinical development dropping to less than 12 percent. The first step towards reducing cycle times and costs involved in conducting clinical research is the identification of bottlenecks.
A Guide to Risk-Based Study Startup: Using big data to overcome cumbersome study-start up processes
Applied Clinical Trials:: The process of initiating clinical trials is cumbersome, challenging and fraught with delays—it has the greatest impact on patient recruitment, trial duration and its associated costs, unfortunately, it is also the worst performing stage of any clinical trial. Study startup is the most resource- and labor-intensive period in a study's life cycle after data cleaning and database lock activities. Any increase of duration or responsibilities during startup has an increased logistical and financial impact.
Big Data Barriers in Healthcare
Advance for Health Information Professionals:: In healthcare, harnessing and unlocking the potential in existing data sources, including clinical trials, biomedical imaging studies, EHRs, genomic and personal health data, can provide insights to improve decision making in all aspects of clinical trial design and drug development.
PM360 Innovators 2015: Products
PM360:: PM360's Innovations Issue, established four years ago, serves as a comprehensive guide to our readers, providing a glimpse at the year's most cutting-edge: Companies, Divisions, Startups, Products, Services and Strategies.
goBalto lands global site activation software deal with ICON
FierceBiotechIT:: goBalto has landed a deal with ICON that will see its site activation software used across all of the CRO's global studies. The agreement gives ICON another tool with which to shorten study startup times, potentially helping it to accelerate the rate at which it burns through its backlog of bookings.
goBalto goes for Speed by Reducing Manual Processes in Study Startups
Outsourcing-Pharma.com:: A focus on study startup can reduce cycle times, mitigate risks, and ultimately eliminate operational bottlenecks, which can result in delays or derailment of clinical trials—it is the key to accelerating clinical trials, reducing costs, and speeding the availability of therapies to patients.
Bringing Transparency and Collaboration to CRO Oversight
Contract Pharma:: The connection between sponsors and contract research organizations (CROs) is strengthening as outsourcing continues to be a clinical trial mainstay. Making the relationship between the sponsor and the CRO as productive as possible means acknowledging the ongoing transition away from tactical projects and toward strategic partnerships, with both stakeholders having a vested interest.
Speeding Study Startup Through Better Collaboration and Data Flow
Clinical Informatics News:: A critical question facing many sponsors and contract research organizations (CROs) is whether another system to support study startup (SSU) is really needed. It's a fair question in the clinical world where the urgent need for better execution of clinical trials has led to a proliferation of technologies, namely the clinical trial management system (CTMS); the electronic trial master file (eTMF); electronic data capture (EDC); and others. Each of these solutions focuses on specific pieces of the clinical trial continuum, yet, they overlook aspects unique to SSU, a complex process that continues to stumble and stall clinical trial timelines.
Accelerating Clinical Trials
Advance for Health Information Professionals:: With thousands of investigational pharmaceuticals, biologics and medical devices in clinical trials, there is constant, intense pressure to bring promising candidates to market as soon as possible. As seriously ill patients worldwide wait for these new therapies, complicated study protocols, globalization and paper-based methods of conducting trials continue to delay market entry.
Stumbling Seven Times but Recovering Eight
Applied Clinical Trials:: Insights for Pharma Executives Sourcing Global Clinical Trials in the U.S. and Japan
Though a highly attractive market, historically Japan has been insular—a consequence of a number of factors, such as medical culture and the complexity of the underlying regulatory context. One of the nuances of this environment was the so-called "drug-lag," where new drug approvals could lag up to six years behind U.S. and European Union (EU) approval. Because of these delays, companies often didn't bother to pursue drug development.
BI the Way
International Clinical Trials:: The clinical trials sector is heavily invested in technologies that track how studies unfold, but putting that information to good use requires turning real-time visibility into actionable data. It is not enough for a sponsor to know that one site enrols quicker or is speedier than others at turning around the study budget. Instead, it is more effective to understand what it takes for all sites to complete those tasks in a timely manner and where the bottlenecks are, so steps can be taken to turn more sites into high achievers.
Study Startup: New Battleground in CRO Differentiation Strategy
Drug Discovery & Development:: With the CRO market approaching tipping point, forward-thinking CROs are looking to differentiate themselves as competition stiffens. Differentiation is an opportunity for CROs as they move away from commoditized, tactical service offerings emphasizing lowest price, in favor of becoming risk-sharing strategic partners in the race for faster and higher quality clinical trials. At a time when study startup (SSU) remains a perpetual bottleneck, CROs that embrace solutions that confront this challenge may be positioning themselves as a step ahead of the competition.
How Much Transparency Is Too Much With Clinical Trials?
Life Science Leader:: There is a growing movement by some researchers and regulators to increase disclosure of clinical trial results. According to advocates, the push for greater transparency would result in the publication of all clinical trial results, including those currently under investigation, as well as past trials conducted. In response, several pharmaceutical companies have publically embraced the concept of clinical trial transparency, notably AstraZeneca with the recent creation of a Scientific Review Board to independently assess requests for data.
The CenterWatch Monthly:: Q. As head of goBalto, a developer of cloud-based programs that accelerate clinical study startup, what specific steps can CROs take to lower startup expenses today that were not available 10 years ago and why is oversight such a hot topic with sponsors now?
goBalto making tracks with platform adoption
DDNews:: goBalto touts a variety of ways in which its Activate service can support CROs, including data sharing, improving quality and reducing cycle time by 66 percent. The company asserts on its website that the Activate platform can help lower the average cycle time for CROs to complete registration documents from an average of 35 days to just 14. Activate also allows organizations to automate workflows to alert for and track when submissions are due, and offers workflow templates to help define the regulatory documents and submissions required for more than 60 countries.
Q&A: Mush, you huskies!
DDNews:: Editor interview with goBalto's CEO Sujay Jadhav.
Expediting Study Startup Across The Globe
Applied Clinical Trials:: The need for more efficient clinical trials is driving greater use of cloud-based solutions, especially with the rise in globalization, a trend that is seeing participating sites venturing full force into regions such as Eastern Europe, Latin America and Asian countries. But this opportunity is not without its challenges. Conducting clinical trials in places with unfamiliar regulatory pathways, cultural differences, and limited infrastructure is highlighting the value of technology that streamlines a key bottleneck—study startup—allowing stakeholders to better adhere to established timelines and budgets.
Bringing Speed to Study Startup
Drug Discovery & Development:: There is intense pressure to speed clinical trials and restrain costs, but inefficiencies tied to complicated protocols, globalization, and paper-based methods have stalled these efforts. The current status of clinical trials has encouraged stakeholders to embrace cloud-based solutions such as clinical trial management systems (CTMS), and the electronic trial master file (eTMF), but one key bottleneck, study startup (SSU), has been largely overlooked.
The Need For Speed In Clinical Study Startup
Outsourced Pharma:: The status of clinical trials continues to stymie industry stakeholders anxious to rein in the cost of product development and adhere to tighter timelines. Despite intense pressure to speed development, mounting evidence documents ongoing inefficiencies tied to complicated protocols, globalization, and old-school paper-based processes, driving clinical stakeholders to embrace technologies that are finally moving the needle.
The Achilles Heel of Clinical Trial Study Startup—Bottlenecks
Biospace:: Over the past decade the capitalized cost to develop an approved new drug has more than doubled from $1,044M in 2003 to $2,558M in 2013 (source: CSDD, 2015), and although some have labeled this as publicized propaganda....
Speeding Clinical Trials Through eClinical Systems
Applied Clinical Trials:: Testing the safety and efficacy of new drugs is a costly and complex process for pharmaceutical organizations. The rising cost and complexity compromises....
At SCOPE 2015, goBalto unveils results of rapid company growth
Clinical Informatics News:: goBalto spent 2014 enhancing its products, automating processes, and investing in customer support and infrastructure....
goBalto looks at ways to speed up clinical trial setup
MedCityNews:: goBalto uses its recent fundraise to speed up not only clinical study startup, but also other aspects of clinical trials, including patient recruitment....
Using Technology to Improve Study Startup
Contract Pharma:: The 1980s saw an escalation in the number of CROs serving global biopharmaceutical companies. In its initial uses, technology always focused on the clinical study conduct phase....
Predictions for 2015: Trends in Clinical Trial Processes
Applied Clinical Trials:: The current pressure on sponsors and contract research organizations (CROs) to execute clinical trials quickly and effectively is on the increase....
Ed Miseta interviews goBalto's Sandi Freeman on how technology will impact clinical trials in 2015
Clinical Leader:: As a new guard comes along and people become more confident with electronic solutions, the reliance on paper-based clinical trial processes may finally be shifting....
Sandi Freeman discusses trusted collaboration with Pharmaceutical Compliance Monitor
Pharma Compliance Monitor:: Although there are obvious benefits to outsourcing, it creates new challenges around quality, oversight, collaboration, and governance....
goBalto spreads its wings in Singapore, UK
PharmaTimes Online:: goBalto, the US-headquartered provider of cloud-based solutions to faciltiate clinical-trial start-ups and workflows, is expanding its international reach with new locations in Singapore and the UK....
Fierce's Top 10 Biotech Techies - 2013
FierceBioIT:: Read the profiles in our second annual "Top 10 Biotech Techies" report and you'll see what this term means to us - people who combine the best of high technology and biotechnology to solve major problems in healthcare....
goBalto wants to save Big Pharma from bungling one big thing
Fierce BioTechIT:: Huge and scary numbers accompany the costs of drug development, including a study last year in Forbes that averaged the total spending per new med from several top pharma groups at $4 billion. Yikes. Behind that ...
goBalto Raises $12M Series B for Cloud-Based Clinical Trials Software
Dow Jones:: goBalto Inc., which makes cloud-based software to simplify clinical trials for pharmaceutical companies and research organizations, has raised a $12 million Series B round...
The Daily Startup: With Big Rivals, goBalto Gets Richer
Wall Street Journal:: goBalto, which makes cloud-based software to simplify clinical trials for pharmaceutical companies and...
goBalto Receives ’Special Recognition’ Award
Partnerships in Clinical Trials:: The 2nd Annual Partnerships in Clinical Trials Awards took place in March 2012 where the conference honored some of the valued members of the clinical trials community. Congratulations to all of our winners!
Innovation needed to kick-start eClinical sector; goBalto
Outsourcing Pharma.com:: A "tectonic shift" will kick-start eClinical innovation and move the sector beyond...
goBalto Study Startup
ClinPage:: In the unofficial design manual for clinical trial software programs, there are numerous unwritten rules but only a single severe commandment...
goBalto’s Three Easy Steps to Study Startup
Bio-IT World:: Online portal goBalto.com is about to formally launch Tracker, the industry’s first web-based platform devoted to clinical study startup, inspired by the user-friendly “look and feel” of consumer-facing outfits like Amazon.com, Salesforce, and Facebook.
Inside San Francisco based - Pivotal Labs, the Agile Force Behind Twitter, Groupon, Gowalla and goBalto
GigaOM:: Pivotal Labs is a name that comes up often in regards to web startups, but it’s sort of an enigma. The company’s San Francisco office is home to the hyped-up distributed social networking effort Diaspora; its work has been credited for shaping Twitter’s development culture; and its clients include Groupon, Gowalla and Best Buy’s “Remix” API project. But what exactly does Pivotal Labs do?
goBalto Grows Matchmaking Portal
GigaOM:: The online portal goBalto.com is the quintessential Silicon Valley start-up, run by eight passionate, mostly 20-something big business types with the entrepreneurial charm to attract capital and the litheness to adopt new ideas quickly. The latter trait allowed goBalto to radically shift direction last December, after joining Eric Ries’ Lean Startup crusade to build new companies by better engaging customers.
Winners of the 2010 Best Practices Program
Bio-IT World:: Bio-IT World has just announced the winners of its sixth Best Practices Awards program. Grand Prize winners from six life sciences awards categories were Bristol-Myers Squibb, The Scripps Research Institute, PROOF / iCAPTURE Centre of Excellence, Massachusetts Institute of Technology, Centocor R&D, and FDA. The competition’s second Judges’ Prize was awarded to goBalto.com...
The Matchmaking Market
The Scientist:: Last August, Kunhua Chen, CEO at Exon Biosystems—a San Diego–based contract research organization (CRO) specializing in protein services—got a request from Elan Pharmaceuticals for a quote to sequence 14 antibodies. Recognizing the fit between his company’s abilities and the requested work, he responded right away. Two weeks later he got an email that Elan was ready to order. A month after that, he struck a deal for $80,000—the biggest project in the company’s three and a half year history.
goBalto adds sites in “high growth” Latin American market
Outsourcing Pharma.com:: Drug development partnering site goBalto’s addition of Latin American clinical sites to its database in a deal with Chilean CRO Clinical Trials Support (CTS) is timely given the pharma and biotech industry’s focus on emerging markets.
10 Promising Companies Selected as Finalists to Present to Leading Investors at LifeScienceFest 2009
Business Wire:: More than 120 of the medical device and life science industry’s top investors, innovators and executives will gather on September 9, 2009 in Menlo Park as we showcase promising early stage innovations from medical devices, diagnostics and bio-informatics.
Clinical Trials Support adds Latin American sites to goBalto
PharmaTimes Online:: More than 950 investigator sites and hospitals in Latin America have been added to goBalto, the online partnering site for the pharmaceutical development and manufacturing sectors.
goBalto Drug Development Partnering WebSite to Include Clinical Trials Support’s List of Investigator Sites
PRWeb:: goBalto, an online drug development partnering site for the pharmaceutical development and drug manufacturing industry, announced today that Clinical Trials Support is making its proprietary list of over 950 Latin American-based Investigator Sites and hospitals available on goBalto.com.
Sponsors Run to goBalto.com to Size Up Service Providers
eCliniqua:: A newly launched website—goBalto.com—is providing the drug development industry with unprecedented intelligence about their would-be partners around the world.
Contract research on the rise
TheScientist:: The global economic crisis has got most businesses pinching pennies just to stay afloat, and the drug development industry is no exception. But at least one sector of the biotechnology sector -- contract research organizations (CROs) -- is on the rise.
PharmaView: Pharma CMOs, Meet Web 2.0
PharmaManufacturing.com:: How do you rate? With goBalto, your clients can tell all. One of the virtues of the Internet age is that you need never shop uninformed. In the market for a car? Educate on Edmunds. An electrician? Angie’s List. A book, a board game? Ask Amazon.
goBalto Partners with Pharma Services Network to Help Sponsors Evaluate Leading CROs
PRWeb:: SAN FRANCISCO, CA – June 23, 2009 – goBalto, a professional social networking site for the pharmaceutical development and drug manufacturing industry, announced today that Pharma Services Network is making its proprietary list of Clinical Research Organizations (CROs) available on goBalto.com.
ChinaBio Names Official Partners for Partnering Forum in Shanghai
Reuters:: The ChinaBio Partnering Forum to be held on June 23-24, 2009, in Shanghai, has announced its Official Partners for the event: BayHelix, BioCentury Publishing, BusinessWire, goBalto.com, GVA Kidder Matthews, Nature Publishing Group and OneMedPlace.
goBalto sets up website for Pharma industry
Manufacturing Chemist:: US-based goBalto has set up a website at www.gobalto.com to enable drug-development companies to find partners, share knowledge, and discover opportunities.
Maya Clinicals partnership extends goBalto site reach to India
PharmaTimes Online:: The roster of more than 7,000 service providers on goBalto, an online drug development partnering site launched just last month, has now expanded to include investigator sites and hospitals in India, through a partnership with locally active contract research organisation (CRO) Maya Clinicals.
goBalto Partners with Maya Clinicals to Expand Bio-Medicine:: Its List of Investigator Sites
goBalto, an online drug development partnering site for the pharmaceutical development and drug manufacturing industry, announced today that Maya Clinicals is making its proprietary list of India-based Investigator Sites and hospitals available on goBalto.com.
goBalto adds ChinaBio’s list of contract research organisations to website
Manufacturing Chemist:: US-based goBalto, a website that enables drug development companies to find partners, share knowledge and discover opportunities, has put ChinaBio’s proprietary list of more than 260 China-based contract research organisations (CROs) and contract manufacturing organisations (CMOs) up on the site.
More on China Biotech Deals: M&A Numbers Misleading
Seeking Alpha:: ChinaBio® LLC agreed to publish its proprietary list of over 260 China-based Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) on goBalto.com.
goBalto, Inc. Partners With ChinaBio to Expand Its List of Contract Research Organizations
BioSPace:: goBalto, an online drug development partnering site for the pharmaceutical development and drug manufacturing industry, announced today that ChinaBio(R) LLC is making its proprietary list of over 260 China-based Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) available on goBalto.com. goBalto recently launched their web-based platform that enables members to quickly and efficiently find partners, share knowledge and discover opportunities.
ChinaBio® Publishes Proprietary China CRO/CMO List on goBalto
ChinaBio Today:: ChinaBio® LLC is making its proprietary list of over 260 China-based Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) available on goBalto.com.
goBalto Partners With ChinaBio to Expand Its List of Contract Research Organizations
San Francisco Business Times:: goBalto, an online drug development partnering site for the pharmaceutical development and drug manufacturing industry, announced today that ChinaBio(R) LLC is making its proprietary list of over 260 China-based Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) available on goBalto.com.
Jae Chung, Co-Founder and CEO of goBalto, Unveils New Web-Based Platform
McKinsey and Company:: Jae Chung (SEO 00-02), CEO and co-founder of goBalto, a dedicated online drug development partnering site for the pharmaceutical and drug manufacturing industry, has unveiled the company's new web-based platform and website, goBalto.com.
Brand design for a pharmaceutical industry game changer
Jae Chung came to Hot Studio this Fall with a bold new business idea for changing the way pharmaceutical companies find, evaluate, and collaborate with qualified partners.