New research focusing on the diffusion of eClinical technology in the study startup phase of clinical trials including: site selection, patient recruitment, contracting and process optimization, application implementation and integration, and outsourcing.
Today marks the next phase in a journey that started 10 years ago.
The final step in the study startup process is the Site Initiation Visit (SIV).
The collection of regulatory documents (also known as, "essential" documents) is the most important part of the study startup process, which ensure that sites are eligible to conduct a study.
It is rare for an original CTA template to be accepted verbatim by sites when they receive the first draft from the sponsor. This is not a bad thing; quite the contrary – negotiation is important part of the process and should serve to meet the needs of all parties.
Investment key to process and quality improvements in the initialization of clinical trials
Performance metrics hold the key to study startup optimization
The DIA Annual Meeting, Boston, MA (June 24-28), is the largest multidisciplinary event of its kind bringing together a global network of life sciences professionals.
goBalto spearheads initiative to bring standardization to the eClinical stack
The clinical trial agreement (CTA) can go by other names, such as the contract, the budget, or Investigator Commitment. The CTA is a mandatory business, legal, and financial element and, like many other documents in the clinical trial startup process, it is often responsible for substantial site activation delays of days, weeks, or even months.
Investment pivotal to improving clinical data flow; shortens trial timelines and reduces costs
Operational transparency pivotal to process optimization and cycle time reductions
In order for a sponsor to find the number of research sites they need for a given protocol, they must engage sites that have confirmed both their capabilities and the availability of the patient population to conduct the study.
Sponsors need to assess whether sites have the required facilities and knowledgeable staff to successfully enroll patients and produce high-quality data for a clinical trial.
Research focused on broad and holistic practices associated with site identification, selection and activation
Sponsors must collect and fully execute Confidentiality Disclosure Agreements (CDAs) with all sites and investigators intended for inclusion in the clinical trial.
Focus on operational efficiencies and effectiveness key to tackling entrenched study startup bottlenecks
Once sponsors have generated a short list of investigative sites, the next step is to contact the sites to start the process of assessing their interest in participating in the study. While the process varies by sponsor/CRO, some type of communication is needed to alert the sites to the upcoming study opportunity.
According to research from Tufts Center for the Study of Drug Development (CSDD), 37% of sites selected for clinical trial studies under-enroll, and 11% fail to enroll a single subject. Eventually, 89% of studies meet enrollment goals, but often at the expense of sponsors faced with doubling the original timeline due to poor enrollment.
Clinical trials that get off to a good start are more likely to be successful trials. The study startup phase is where this happens, and includes such activities as; investigator selection, regulatory and ethics submissions, site training and ends with the site initiation visits.
Get to know the steps and bottlenecks when starting a clinical study
Key business optimization features and operational enhancements reduce complexities and speed study startup
Gathering of key industry executives provides forum for open dialogue on issues affecting the initiation of clinical trials
Adoption of leading innovative platform spanning the Study Startup continuum key to stemming inefficiencies endemic in Industry
Integration improves efficiencies and accurancy in the selection of high performing sites
Global CRO utilizes study startup automation to reduce trial complexity and improve operational transparency
Research on inefficiencies associated with starting clinical trials presented to leading pharma and CRO organizations.
The outsourcing of clinical research activities is anticipated to increase steadily to 72% by 2020, up from just 23% in 2012. When we think of outsourcing, we need to remind ourselves of the Sponsor and CRO goals.
Engagement reflects adoption of industry proven study startup solutions.
Speeding trial deployments from site identification to activation, while ensuring regulatory compliance
International expansion reinforces goBalto’s leadership position in Study Startup, essential for speeding clinical trials and the delivery of life saving therapies to patients.
The DIA Annual Meeting, Philadelphia, PA (June 26-30), is the largest multidisciplinary event of its kind bringing together a global network of life sciences professionals.
You are invited to attend the MCC Feasibility/Study Start-Up and Risk Management/KRI meetings to be held in May in Princeton, NJ, Durham, NC, and Boston, MA. Please join the MCC staff and distinguished speakers for a complimentary breakfast and informative discussions.
As a member of the Leadership Group, goBalto and the Metrics Champion Consortium member organizations will collaborate to define industry benchmark measures for organizations engaged in starting clinical trials.
A critical question facing many sponsors and contract research organizations (CROs) is whether another system to support study startup (SSU) is really needed.
The potential of eClinical technologies can be optimized through the use of cloud-based tools for analyzing business intelligence, with actionable visual reports helping to identify study bottlenecks and improve performance.
CenterWatch editor interviews Jae Chung, goBalto's President and Founder on vendor oversight.
With thousands of investigational pharmaceuticals, biologics, and medical devices in clinical trials, there is intense pressure to speed them along so the more promising candidates will come to market sooner.
The drug development process is long, arduous, and costly, driving many sponsors to consider greater use of contract research organizations (CROs). This move reflects sponsors' sharper focus on core competencies and the shifting of management and conducting of clinical trials to CROs.
During the last several decades, the pharmaceutical industry has delivered a multitude of life-saving medicines, creating new treatment options for a variety of unmet medical needs.
Many sponsors are soliciting the services of CROs that employ process-driven clinical research methods. Designed to help achieve more predictable costs and actionable results, CROs employing these methods are speeding the R&D process, while reducing trial risks.
Industry leaders are adopting ‘best of breed’ applications in eClinical stack to speed clinical trials.
According to a recent article in TechTarget, clinical trials are horrible things. Although Biopharma is lead by scientific endeavor, and only has patient safety and therapeutic benefits in mind, the process of bringing drugs to market is long, complex, bureaucratic and, above all else, expensive.
New European clinical trial regulations aim to reduce administrative burden and costs. goBalto's "smart" workflows harmonize clinical trial expediency and compliance, creating an environment that is favorable for conducting clinical trials across the European Union.
According to a recently released report from Research and Markets by 2020 the average clinical trial outsourcing penetration will likely reach around 72%. Although there are obvious benefits to outsourcing, it creates new challenges around quality, oversight, collaboration, and governance.
Industry standard in study startup adds robust team management and submission planning features. The third major release of 2015 offers new features that further accelerate clinical study startup.
Drug Discovery News editor interviews Sujay Jadhav, goBalto's CEO on the company, products and future plans.
The 5th Annual Disruptive Innovations to Advance Clinical Trials (September 10-11) conference is the definitive event for innovators in the clinical trial space. The entire conference introduces novel and bold approaches to help attendees think differently about how we do 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.
There's no doubt that a clinical trial management system (CTMS) is vital to the clinical trial process. Primarily focusing on study execution, CTMS solutions are meant to manage all aspects of the trial process; they're built to be all encompassing. But over time clinical trials have become too complex for one single system to handle.
As Craig Morgan recently pointed out in this two-part series, there is a critical and undeniable need for speed in clinical trials. E-signatures are an important step towards the automation of clinical trials.
Partnership bolsters collaboration with clinical research sites.
The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials—it is a bottleneck at the outset that slows drug development, leading to significant delays and costs.
The pharmaceutical industry has been on the defensive against the escalating cost of medicines, ethical issues associated with globalization of clinical trials, and access to new innovative treatments.
I have written several articles recently about companies in the pharma industry that continue to use paper for clinical trials when technology now exists to make all of it obsolete.
Advanced, cloud-based collaboration platforms allow sponsors, CROs, and sites to dramatically reduce study startup timelines, eliminate bottlenecks, and reduce costs.
The clinical trial landscape is ripe for bringing substantial improvements to the SSU process.
The status of clinical trials continues to stymie industry stakeholders anxious to rein in the cost of product development and adhere to tighter timelines.
Industry standard in clinical study startup adds robust project management and business optimization features
Rapid adoption of award winning study startup solutions drive market penetration in Life Sciences industry
The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials. Many organizations struggle to control costs and resources associated with ramping up clinical trials.
In a previous blog post, Usability in action, I discussed conducting interviews and usability sessions to understand your users' needs, and how to use these tools to develop your designs. But wait, there's more—or, there are steps to take before moving on to usability.
The DIA Annual Meeting, held recently in Washington D.C. (June 14-18), is the largest multidisciplinary event of its kind bringing together a global network of life sciences professionals.
We've all heard the saying, "test early and test often." When I first began doing usability testing, I was scared to death. I cowered behind my designs, wanting to test later and test seldom. Why?
Testing the safety and efficacy of new drugs is a costly and complex process for pharmaceutical organizations. The rising cost and complexity compromises profitability and can stifle research and innovation.
Clinical Research Organizations (CRO) that specialize in clinical trials offer sponsors the expertise of moving a new drug or device from its conception to FDA marketing approval, without the sponsor having to incur costs associated with staffing these services.
Outsourcing different aspects of the clinical study process is a growing trend; 64 percent of trials are currently outsourced. Of those that don't currently, 54 percent plan to outsource in the future, according to a survey conducted by Clinical Informatics News.
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).
We bring significant technological disruptions to the historically inefficient and error prone startup stages in clinical trials inspite of being told by industry veterans that, "you can't bring standards to study startup because of regulatory complexities, people's tendencies to not change, and that people have tried before, etc."
True integration is critical to plug and play coexistence
goBalto is the only non-TMF vendor to have released a fully integrated framework based on the new DIA TMF reference model (version 3.0) XML-based exchange mechanism (see "A new eTMF Exchange Initative: Presentation at the DIA eRegulatory and Intelligence Conference" by Paul Fenton, chair of DIA TMF reference model V3 Exchange Group).
As clinical trials increasingly are conducted outside the US, Pharma and CROs face both opportunity and challenge especially in emerging markets.
Vendors selected for the "Cool Vendor" report are innovative, impactful and intriguing. Gartner's Cool Vendor research "is designed to highlight interesting, new and innovative vendors, products and services."
Study startup is the process of (i) identifying and (ii) activating investigative sites. Historically, the study startup phase has been viewed as inherently inefficient and error prone—the workhorse of clinical trials being labor intensive, costly, and time-consuming.
There's no doubt that a electronic trial master file (eTMF) is vital to the clinical trial process, to comply with regulatory requirements by securely maintaining and storing essential trial documents.
Before we answer this question, let's just state for the record: an eTMF is an important tool for organizing your clinical study startup documents and providing easy access to those documents. An eTMF plays a central role in the submission and closeout phase of the trials process.
The question of whether existing technologies like eTMF can manage study startup often comes up when I meet with clinical trial sponsors and CROs. There’s a lot of confusion in the market about what these systems can and cannot do, for a few reasons.
SSU process improvement: a brief history
In the early days of contract research organizations (CROs), when just a handful of CROs existed, big pharma handled most of their own clinical development.
In last month’s post, Steve Winter discussed the elements of effective user experience design. goBalto uX Designer Tammy Coombs highlights the people aspect of UX design and shares details of a usability visit with a goBalto partner.
Effective user experience (UX) design requires a deep understanding of users, what they need, what they value, and their goals and expectations of an application. We study and evaluate how people get things done, and translate this into an elegant user interface.
Yes, patient recruitment continues to be a major bottleneck in clinical research. Just as it was a decade ago, about a third (37%) of sites in a given trial still fail to reach their enrollment goals, and 11% fail to enroll any subjects at all.
The recent article Consistent Trial Site Payments Key to Long-Term Relationships with Investigators (25JUL2013) highlights that “CROs and sponsors look to retain their most highly-prized sites and establish long-term relationships for future trials.”
Status quo and how things are changing
Performing 100% Source Document Verification (SDV) has been the gold standard for years in clinical research. CRAs spent much of their careers checking every datapoint on CRFs against Source Data.
Whether it's a customer demo, investor pitch, friends, family and random folks on the internet - we get this questions all the time. Where does the name goBalto come from and what does it mean? Here's the story.
Study sites have numerous responsibilities and must perform a daunting number of tasks. The one aspect of conducting clinical trials that sites usually spend the most time working on is Patient Recruitment, and yet, statistics show that despite their efforts, reaching enrollment goals per timeline is frustratingly elusive in many studies.
The Trial Master File (TMF) is the heart of every clinical trial. The TMF often paper/binder based is a collection of essential regulatory documents which are required to initiate a trial within an investigative site.
Did you know over 80% of study managers use a spreadsheet to track site activation tasks? Not surprising, considering Excel is widely accessible, affordable and easy to use (in the short run). However, these benefits become quickly negated when you are seeking to activate more than a handful of sites.
This is the 10th and final installment of our series on 10 Steps to Clinical Study Start Up. We hope you enjoyed it. And of course feedback/comments/thoughts are welcome!