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trends & perspectives in clinical research

goBalto Chromosome

Disrupting Clinical Operations with CRO Strategic Partnerships

by Craig Morgan
21Sep2017

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.

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goBalto Named Scrip Awards Finalist 2017

by Craig Morgan
19Sep2017

Awards recognize goBalto's Select in the 'Best Technological Development in Clinical Trials - Sponsor-Focused' category.

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How Effective are Study Startup Regulations?

by Craig Morgan
18Sep2017

An operational approach to protocol amendments helps ensure document completeness and lineage

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Upfront Planning Crucial to Process Improvements and Quality in Clinical Trials

by Craig Morgan
14Sep2017

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.

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Webinar: Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?

by Craig Morgan
11Sep2017

Save your seat for this upcoming webinar! Emphasis on quality is everywhere, but in particular, the study startup (SSU) portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.

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How CROs are Helping with Healthcare's Data Problem

by Sujay Jadhav
07Sep2017

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.

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The Illusion of Safety

by Craig Morgan
04Sep2017

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.

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Are Clinical Research Sites a Dying Paradigm?

by Craig Morgan
31Aug2017

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.

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Why the Cloud is Pivotal to Speeding Clinical Trials

by Craig Morgan
28Aug2017

Clinical trials are growing in complexity – complicated further by the convolution of demand, outsourcing and globalization.

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Improving Minorities' Participation in Drug Trails can Help Reverse Rising Healthcare Costs

by Sujay Jadhav
21Aug2017

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.

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Webinar: Moving Beyond Regulatory and Performance Metrics in Starting Clinical Trials

by Craig Morgan
14Aug2017

Save your seat for this upcoming webinar! Trial metrics are critical to risk mitigation and a preemptive weapon in the fight against the dreaded rescue study.

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Myopic Focus on Dashboards May Blur Insights

by Craig Morgan
07Aug2017

There is intense pressure to speed clinical trials and restrain costs. Given the burden of this duality, clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data—at a faster pace, while sponsors and contract research organizations (CROs) are looking for ways to incorporate business intelligence (BI) into the eClinical systems they are using to empower oversight—turning raw trial data into actionable information.

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The Vanguard of Patient Centricity: Patient-Led Clinical Trials

by Craig Morgan
31Jul2017

Challenging the 'status quo' of the Randomized Clinical Trial (RCT) model, with the concept of Patient-Led Clinical Trials.

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Are Local IRBs Really Necessary?

by Jae Chung
31Jul2017

Before research on human subjects can begin, federal regulations require independent review and approval by an institutional review board (IRB). An IRB is a committee established to protect the rights, safety and well-being of humans involved in a clinical trial.

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Using Real World Data to Enhance Clinical Trials

by Sujay Jadhav
24Jul2017

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.

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Modeling and Simulation in Clinical Trials: Real Potential or Hype?

by Sujay Jadhav
17Jul2017

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.

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Webinar: Uncovering Trial Bottlenecks with Performance vs. Regulatory Metrics

by Craig Morgan
10Jul2017

Save your seat for this upcoming webinar! The sharpening focus on quality management is fueling greater use of standardized metrics to optimize clinical trial performance.

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Overcoming the Innovation Malaise

by Craig Morgan
03Jul2017

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.

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It's Time to Rethink Site Engagement

by Craig Morgan
29Jun2017

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 ecosystem.

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ChromoReport: Focusing on Study Startup Performance by Therapeutic Areas

by Craig Morgan
26Jun2017

Standardized performance metrics that are actionable drive transparency and process improvement

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Simplifying the Clinical Study Startup Process

by Sujay Jadhav
22Jun2017

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.

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Webinar: Improving Study Startup Efficiency

by Craig Morgan
12Jun2017

Save your seat for this upcoming webinar! Paragon Solutions and goBalto discuss leveraging technology & business process optimization to drive change in study startup.

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Alternative Fact: Site Identification is not Critical to Clinical Trial Efficiency

by Jae Chung
05Jun2017

On the surface this may seem to have some validity, as sponsors and contract research organizations (CROs) often lack a transparent, evidence-based strategy for this task.

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Are Clinical Trial Matching Services Truly Patient-Centric?

by Sujay Jadhav
29May2017

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. For example, in the age of precision medicine, oncologists often offer multiple treatment options, from FDA approved indications to experimental therapeutics that are not yet on the market.

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First Mover Does Not Always a Market Leader Make

by Sujay Jadhav
22May2017

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.

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How Patients Will Revolutionize Next-Generation Clinical Research

by Jae Chung
15May2017

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

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Webinar: To Centralize Site Selection and Startup or Not? That is the Question.

by Craig Morgan
08May2017

Save your seat for this upcoming webinar! New Tufts CSDD study evaluates the impact of centralized investigative site management—identification, feasibility, selection and activation—on cycle time reduction.

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Automating Investigational Product Green Light Release to eTMF

by Craig Morgan
01May2017

Providing audit ready visibility into an artifact's status, that is not yet filed in the eTMF.

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Will Special Interests Derail the Future of Personalized Medicine?

by Sujay Jadhav
24Apr2017

Treatment of cancer using chemotherapy (chemo) drugs began soon after WWII, when a compound called nitrogen mustard was studied and found to work against cancer in the lymph nodes. In the years that followed, many chemo drugs have been developed that work by non-selectively inhibiting rapidly dividing cells.

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10 Tips for Selecting High Performing Clinical Sites

by Craig Morgan
17Apr2017

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.

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Webinar: New Tufts CSDD Study on End-to-End Site Identification Through Startup

by Craig Morgan
10Apr2017

Save your seat for this upcoming webinar! New study assessing sponsor and CRO experience, practices and improvement areas associated with investigative site identification, feasibility, selection and study startup.

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Why is there such Inefficiency in Site Selection?

by Jae Chung
03Apr2017

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.

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goBalto Releases Industry's First Study Startup Performance Metrics Report

by Craig Morgan
30Mar2017

Standardized performance metrics that are actionable drive transparency and process improvement

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INC Research Accelerates Clinical Trial Start-up with goBalto Activate

by Craig Morgan
28Mar2017

Global CRO utilizes study startup automation to reduce trial complexity and improve operational transparency

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Accelerating Innovation to Cut Drug Prices

by Craig Morgan
27Mar2017

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.

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goBalto Awarded Top 20 Most Promising Biotech Technology Solution Providers 2017

by Craig Morgan
23Mar2017

goBalto has been selected by CIOReview for the second consecutive time as one of the 20 Most Promising Biotech Technology Solution Providers 2017.

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New European Union Regulations Designed to Attract More Clinical Trials

by Craig Morgan
20Mar2017

Modern medicine has come a long way since the days of snake oil salesmen. Today, patients can be assured that the medicine they are prescribed has been vetted for safety and efficacy by a long and arduous discovery process guided by governmental regulatory agencies.

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goBalto Named Clinical Research & Excellence Awards Finalist 2017

by Craig Morgan
16Mar2017

The Clinical and Research Excellence Awards recognize goBalto's Select solution in the 'Best Sponsor-Focused Technological Development' category.

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Webinar: Is the Shortage of Experienced CRAs Impacting Clinical Trials?

by Craig Morgan
13Mar2017

Save your seat for this upcoming webinar! The clinical research industry is experiencing a concerning global shortage of experienced Clinical Research Associates (CRAs), with many sponsors and CROs finding themselves in a never-ending recruitment cycle.

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goBalto Study Startup Summit Unveils In-Depth Benchmarking Study

by Craig Morgan
09Mar2017

Research on inefficiencies associated with starting clinical trials presented to leading pharma and CRO organizations.

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Smart Startup: Combining Streamlined Processes & Leading Edge Technology

by Craig Morgan
06Mar2017

"Having a dedicated start-up team, the transparency of start-up progress within Activate and the Analyze reports enabled the project manager and the sponsor to have real time access to study start-up progress."

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A Step Change in Study Startup Efficiency

by Craig Morgan
27Feb2017

"Activate features such as: alerts and to-do lists, role based process flows, milestone tracking (including those on the critical path), and IP release checklists helped drive productivity by creating a central repository with the right supporting workflows."

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Are Delays in Clinical Trials due to a Lack of Experienced CRAs?

by Craig Morgan
20Feb2017

CNN Money recently ranked Clinical Research Associates (CRAs), professionals whose main function is to monitor clinical trials of investigational drugs, as one of the 10 best careers in America in terms of job growth rate, worker pay, and satisfaction.

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Webinar: Are Local IRBs Really Necessary?

by Craig Morgan
13Feb2017

Save your seat for this upcoming webinar! Are local IRBs necessary or just a burden on clinical trials, a bottleneck that contributes to delays and cost overruns?

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Deep Knowledge of Study Startup Points Data in the Right Direction

by Craig Morgan
06Feb2017

Massive volumes of data are generated during clinical trials, but they are woefully inadequate at helping stakeholders spot risk factors and bottlenecks that can disrupt cycle times and budgets.

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Barriers to Increased Participation of Minorities in Clinical Trials

by Sujay Jadhav
30Jan2017

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.

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Moving Beyond Clinical and Operational Metrics in Study Startup

by Craig Morgan
23Jan2017

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.

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Webinar: Eliminating the Three Evil E's in Study Startup

by Craig Morgan
16Jan2017

Save your seat for this upcoming webinar! A paradigm shift is needed in order to eliminate the three evil "e's" – email, Excel, and e-meetings – long associated with starting clinical trials.

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Growing Complexity and Risks in Clinical Trials

by Craig Morgan
09Jan2017

Clinical trials for pharmaceutical products continue to grow in complexity and scope. Research conducted by the Tufts Center for the Study of Drug Development (CSDD) during the past 15 years has demonstrated that, compared to 10 years ago, protocols have more endpoints, procedures, eligibility criteria, CRF (case report form) pages, amendments, and investigative sites—complicated further by the convolution of outsourcing and globalization.

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Fighting the Commoditization of Sites: It Starts with the Site Initiation Visit (SIV)

by Sujay Jadhav
03Jan2017

Despite advancements in clinical research technology over the last decade, recent research from the Tufts Center for the Study of Drug Development (CSDD) suggests that we are not conducting site activation any faster today than we did 20 years ago.

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Clinical Trial to Patient Matching

by Sujay Jadhav
26Dec2016

Despite advancements in clinical research technology over the last decade, recent research from the Tufts Center for the Study of Drug Development (CSDD) suggests that we are not conducting site activation any faster today than we did 20 years ago.

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To you it’s a document. To me it’s my life.

by Jae Chung
19Dec2016

T.J. Sharpe is an ordinary man with an extraordinary story. Faced with the prospect of a Stage IV Melanoma diagnosis back in 2012, he vowed to never give up, determined to see his two young children grow up with a father.

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Could Gamification Improve Clinical Trials?

by Jae Chung
12Dec2016

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.

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Webinar: Why are Metrics Important to Starting Clinical Trials?

by Craig Morgan
05Dec2016

Save your seat for this upcoming webinar! 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.

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A Build vs. Buy Look at Study Activation

by Jae Chung
01Dec2016

With the advent of technology for clinical trials, an old argument plays out each time a new one is introduced. Should stakeholders build their own solution internally or buy an off-the-shelf tool designed for a specific purpose?

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Me-Too's: The Carbon Copy "Innovators"

by Sujay Jadhav
28Nov2016

There has been a long-running debate in the pharmaceutical industry about the value of being first to market. Companies spend considerable resources seeking to increase the odds of beating their competitors to market and often fret about the commercial disadvantage of being late.

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Why are Metrics Important to Starting Clinical Trials?

by Craig Morgan
21Nov2016

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.

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Webinar: Are Delays in Clinical Trials due to a lack of Experienced CRAs?

by Craig Morgan
14Nov2016

Save your seat for this upcoming webinar! The clinical research industry is experiencing a concerning global shortage of experienced Clinical Research Associates (CRAs), with many sponsors and CROs finding themselves in a never-ending recruitment cycle.

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Dangers lurk in an eClinical Monopoly

by Jae Chung
07Nov2016

Clinical Research Organizations (CROs) are often portrayed as the bastions of innovation in the pharmaceutical industry when it comes to running clinical trials, which is not surprising given that outsourcing of trials is estimated to exceed 70% by 2020, and process optimization is key to both their differentiation strategy and increased margins.

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Eliminating the three evil “e’s” from Starting Clinical Trials

by Craig Morgan
31Oct2016

Clinical trials are the bridge to medical innovation. Most people don't think about the origins of the drug they receive or the medical procedures they undergo on a regular basis. Yet every drug, diagnostic test, surgical procedure – medical treatment in any shape or form – finds its origins in a single source: research.

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10 Tips for Enabling Better CRO-Sponsor Collaborations

by Craig Morgan
24Oct2016

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.

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Webinar: Get Selected - How to Attract Sponsors and CROs

by Craig Morgan
20Oct2016

Save your seat for this upcoming webinar! Attracting sponsors/CROs in today's competitive clinical trials landscape and maintaining those relationships is critical for sites that want to get selected for future studies.

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goBalto Study Startup Summit Attracts Leading Pharmaceutical and CRO Organizations

by Craig Morgan
17Oct2016

Engagement reflects adoption of industry proven study startup solutions.

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Securing the High Ground

by Jae Chung
10Oct2016

An interesting take away from the recent Tufts CSDD report is the renewed interest in study startup (SSU) as an area of focus, that many organizations engaged in clinical trials are activity pursuing whether through innovation projects, expanded budgets or dedicated SSU teams.

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Automate SOPs to Streamline Study Startup

by Craig Morgan
03Oct2016

Standard Operating Procedures (SOP) 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.

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Co-Opting Innovation: How Startups and Big Companies Together Accelerate Innovation

by Sujay Jadhav
26Sep2016

The race to innovate is increasingly a top priority for businesses across all sectors. The obvious fact is that only a tiny percentage of companies will prevail. What seems less obvious is that innovation almost always comes from small companies.

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The Importance of Ethnic Diversity in Clinical Trials

by Sujay Jadhav
22Sep2016

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.

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Concomitant Medications in Clinical Trials: Why the Stakes are High

by Sujay Jadhav
19Sep2016

Almost every reported concomitant medication has a reason—and many, if not all of these reasons should be reported as adverse events.

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Webinar: Refocusing on Risk Mitigation in Starting Clinical Trials

by Craig Morgan
15Sep2016

Save your seat for this upcoming webinar! Key to avoiding the need for study rescue, cost overruns, delays in regulatory filing, market entry, and ultimately, delivery of new therapies to patients, is the proper identification of red flags that signal the study is veering off course.

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PSI CRO Adopts goBalto's End-to-End Study Startup Platform for Clinical Trials

by Jae Chung
13Sep2016

Speeding trial deployments from site identification to activation, while ensuring regulatory compliance

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Removing the Blinders in Site Selection

by Craig Morgan
12Sep2016

Investigative sites are the heart and soul of the life sciences sector as they perform the all-important clinical trials.

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DevOps is slowly taking over the IT landscape

by Meredith Courtemanche
08Sep2016

Enterprise IT shops tend to hold on to old technologies, but many are finding ways to standardize, automate and orchestrate them alongside the hot new things.

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It's Site Selection, Not a Toss of the Dice

by Craig Morgan
06Sep2016

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.

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CMIC HOLDINGS, a Leading CRO in Asia Implements goBalto Activate to Accelerate Study Startup

by Jae Chung
01Sep2016

International expansion reinforces goBalto’s leadership position in Study Startup, essential for speeding clinical trials and the delivery of life saving therapies to patients.

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Virtual Clinical Trials: The Future of Patient Engagement?

by Sujay Jadhav
29Aug2016

The clinical trial process plays an essential role in drug discovery by effectively demonstrating the efficacy and safety of a pharmaceutical compound. Unfortunately, current estimates show that only about 1 in 10 drugs that actually start the clinical trials process are eventually granted FDA approval.

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The School of Study Startup Hard Knocks

by Craig Morgan
22Aug2016

Virtually all leaders believe that to stay competitive, their enterprises must learn and improve every day. But even companies revered for their dedication to continuous learning find it difficult to always practice what they preach.

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Webinar: Using eClinical Systems to Speed up Clinical Trials

by Craig Morgan
18Aug2016

Save your seat for this upcoming webinar! While a one-stop eClinical shop sounds appealing, it simply is not possible today. What works best is using and integrating a small number of tools that are purpose-built for specific clinical operational objectives.

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Managing Increasing Complexity in the Clinical Trial Industry

by Craig Morgan
15Aug2016

Clinical trials for pharmaceutical products continue to grow in complexity and scope. Research conducted by the Tufts Center for the Study of Drug Development (CSDD) during the past 15 years has demonstrated that, compared to 10 years ago, protocols have more endpoints, procedures, eligibility criteria, CRF (case report form) pages, amendments, and investigative sites—complicated further by the convolution of outsourcing and globalization.

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Study Accessing Practices and Inefficiencies Associated with Site Selection, Study Start Up and Site Activation

by Ken Getz
11Aug2016

Sponsor and 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.

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The Cloud: Speeding Drug Delivery

by Craig Morgan
08Aug2016

Clinical trials play an essential role in the drug development process by effectively demonstrating the efficacy and safety of a pharmaceutical compound. Current estimates show, however, that only about 1 out of every 10 drugs that actually start the clinical trials process are eventually approved by the FDA to go to market.

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Making Site Selection Precise and Accurate

by Craig Morgan
01Aug2016

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.

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Stop Rolling the Dice in Site Selection

by Craig Morgan
25Jul2016

Alarmingly, an "adverse" event with a selected site is more likely than rolling a 7 in the dice game of craps. The "Lucky 7" denotes gambler's luck and is statistically the most likely number to roll. Selecting the 'right' site to enroll patients is critical to the overall cost and duration of a trial, a process that continues to stymie the industry.

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Breakthroughs in Clinical Trials Utilizing the Power of the Cloud

by Craig Morgan
18Jul2016

Clinical trials play an essential role in the drug development process by effectively demonstrating the efficacy and safety of a pharmaceutical compound. Although lead by scientific endeavor with patient safety and therapeutic benefits in mind, the process of bringing drugs to market is long, complex, bureaucratic and, above all else, expensive.

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Webinar: The last Major Frontier in Automating Clinical Operations - Study Startup

by Craig Morgan
14Jul2016

Save your seat for this upcoming webinar! There has been a strong focus on study conduct, but as stakeholders are increasingly aware that better SSU processes are linked to shorter clinical timelines, the emphasis is shifting in that direction.

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Innovation Detractors in Pharma

by Sujay Jadhav
11Jul2016

In most industries, the pace of technology change has increased so much that corporate IT leaders who don't embrace emerging trends end up behind the competition and eventually out of business. Can we really say the same is true for pharma companies?

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How Can You Make Site Identification And Activation More Efficient?

by Ed Miseta
05Jul2016

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.

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What Ebola can Teach us about Adaptive Trial Design

by Sujay Jadhav
27Jun2016

Evaluating the efficacy of novel therapeutics in the context of epidemics is challenging to say the least, with situations evolving rapidly and heighten ethical concerns about research during public health emergencies.

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Clinical Trials and the Power of the Cloud

by Craig Morgan
20Jun2016

Clinical trials are horrible things, according to a recent article in TechTarget. Although lead by scientific endeavor with patient safety and therapeutic benefits in mind, the process of bringing drugs to market is long, complex, bureaucratic and, above all else, expensive.

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Come see goBalto at DIA 2016

by Jae Chung
16Jun2016

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.

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Integrated Workflows: The Unsexy Plumbing of Clinical Trials

by Craig Morgan
13Jun2016

Technology has been transforming many sectors of the economy and now it is poised to address one of the most manual, error prone, complex, bureaucratic, and, above all else, expensive bottlenecks in the pursuit of new disease treatments—clinical trials.

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Improving Site Selection: Taking off the Blinders

by Craig Morgan
09Jun2016

The pharmaceutical industry continues to face a never-ending onslaught of demands from stakeholders demanding greater clinical trial transparency and regulatory exemptions stemming from growing concerns over costs and lengthy delays in trials, as healthcare costs spiral upwards and patients continue to wait for life saving therapies.

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Webinar: Driving informed decisions in site selection - It's a two-way street

by Craig Morgan
06Jun2016

Save your seat for this upcoming webinar! Risk based site selection is like an informed consent, you need the right information to make the best decision.

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Bringing Transparency and Collaboration to CRO Oversight

by Craig Morgan
31May2016

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.

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Going Virtual: Changing the Clinical Trial Landscape

by Sujay Jadhav
26May2016

Imagine its 2025. Participating in a clinical trial does not require travel to a clinical research facility or doctor's office. Your mobile device (maybe a phone, watch, or even your glasses) is your link to the clinical research study and where you report general information and adverse events.

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Reducing Study Rescue: The Importance of Getting Clinical Trials Off to a Good Start

by Craig Morgan
23May2016

Clinical trials are not for the faint of heart. Conducting even one clinical trial is a monumental task with complex processes and issues that can surface and derail a study's timeline. As a result, delays in regulatory filing, market entry, and ultimately, the delivery of new therapies to patients are all too common.

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Refocusing on Risk Mitigation in Starting Clinical Trials

by Jae Chung
16May2016

Both the FDA and EMA state that risk-based methodologies should begin at the start of a trial, yet in reality most risk management efforts in drug development have focused on post-marketing safety.

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Webinar: The Role of Transparency in CRO-Sponsor Partnerships - Enabling Better Collaboration Models

by Craig Morgan
12May2016

Save your seat for this upcoming webinar! Relationships between sponsors and contract research organizations (CROs) are getting stronger—The connection between sponsors and CROs is strengthening as outsourcing continues to be a clinical trial mainstay.

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From “Muddling Through” to Innovating: Driving Adoption of Technology to Improve Efficiency in Clinical Trials (Part 2)

by Sujay Jadhav
09May2016

In my last blog, I talked about innovation detractors & resistance to change in Pharma. But, just how rational are organizations when they make decisions? This blog is the second part of a two part series.

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Innovation Detractors & Resistance to Change in Pharma: The Elimination of FUD (Part1)

by Sujay Jadhav
02May2016

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.

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Optimizing Clinical Studies

by Jae Chung
28Apr2016

Pharmaceutical companies are constantly looking to innovate and perform business operations in smarter ways, as the costs of drug development have continued to escalate.

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Automating eTMF Generation in a Multi-Partner Ecosystem

by Rob Wynden
25Apr2016

Many sponsors outsource a majority of their clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing, while minimizing the costs of recruiting experts, building a team and maintaining the necessary infrastructure.

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Invitation to MCC Feasibility/Study Startup and Risk Management/KRI meetings

by Craig Morgan
21Apr2016

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.

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A Data Driven Approach to Site Profile Optimization

by Craig Morgan
18Apr2016

Pharma seems to be under an almost daily barrage by stakeholders wanting to see movement in the drug development statistics that have stymied the industry, and are to blame for their lackluster performance, rising healthcare costs and delays in getting much needed therapies to patients.

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Webinar: Tufts Report & Removing the Blinders in Site Selection

by Craig Morgan
14Apr2016

Save your seat for this upcoming webinar! Tufts CSDD presents the findings of a new study assessing practices and inefficiencies associated with site selection, study startup, and site activation in starting clinical trials.

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Utilization of the Crowd for Clinical Research (Part 2)

by Sujay Jadhav
11Apr2016

In my last blog, I suggested utilization of the crowd for funding of clinical research. This blog is the second part of a two part series.

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goBalto Awarded Top 20 Most Promising Biotech Technology Solution Providers by CIOReview Magazine

by Craig Morgan
07Apr2016

Industry proven study startup process optimization key to selection.

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Utilization of the Crowd for Clinical Research (Part 1)

by Sujay Jadhav
04Apr2016

Recent studies have estimated the cost to bring a new drug to market ranges somewhere between $161 million and $2 billion, and these costs are rising rapidly. This blog is the first part of a two part series.

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goBalto Delivers First End-to-End Study Startup Platform for Clinical Trials

by Craig Morgan
31Mar2016

With this mornings release of goBalto Select for site profile optimization, goBalto becomes the first life science software vendor to offer a complete end-to-end platform for starting clinical trials, from site feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget.

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Risk Mitigation Pivotal to Starting Clinical Trials

by Craig Morgan
28Mar2016

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.

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Rethinking "Patient Centricity"

by Sujay Jadhav
24Mar2016

The drug development community is increasingly turning to patient engagement or "patient centricity" approaches to optimize clinical trials costs and improve research outcomes.

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Webinar: New Tufts CSDD Study on Site Selection and Initiation

by Craig Morgan
21Mar2016

Save your seat for this upcoming webinar! Tufts CSDD presents the findings of a new study assessing practices and inefficiencies associated with site selection, study startup, and site activation in starting clinical trials.

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goBalto Named Clinical Research & Excellence Awards Finalist

by Craig Morgan
18Mar2016

The Clinical and Research Excellence Awards recognize goBalto's Activate solution in the 'Best Sponsor-Focused Technological Development' category.

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Better Study Startup Means Less Study Rescue

by Craig Morgan
14Mar2016

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.

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goBalto Partners with Metrics Champion Consortium to Define Benchmarking Metrics for Study Startup

by Jae Chung
10Mar2016

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.

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Barriers to Big Data Innovation in Healthcare

by Sujay Jadhav
07Mar2016

In the last several years, we have seen tremendous advances in the amount of data we routinely generate and collect, as well as our ability to analyze and understand it. The intersection of these trends is what we call "Big Data" and it is helping businesses in every industry to become more efficient and productive.

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Speeding Study Startup Through Better Collaboration and Data Flow

by Barry Milton
29Feb2016

A critical question facing many sponsors and contract research organizations (CROs) is whether another system to support study startup (SSU) is really needed.

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BI the Way

by Craig Morgan
22Feb2016

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.

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Q&A: Bringing Order to Sponsor Oversight

by Ron Rosenberg
15Feb2016

CenterWatch editor interviews Jae Chung, goBalto's President and Founder on vendor oversight.

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Risk mitigation key to successful Study Startup

by Craig Morgan
08Feb2016

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.

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Accelerating Clinical Trials From the Outset

by Craig Morgan
01Feb2016

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.

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goBalto selected by Tech TrailBlazer for Cloud Innovation

by Craig Morgan
27Jan2016

goBalto has been shortlisted as a finalist for the Tech Trailblazers Award in cloud computing category in recognition of it efforts to accelerate clinical trials.

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The Achilles Heel of Study Startup: Bottlenecks

by Craig Morgan
25Jan2016

The clinical trial phase of a drug development program is by far the most costly, risky, and protracted phase of the investigative process.

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goBalto goes for Speed by Reducing Manual Processes in Study Startups

by Melissa Fassbender
18Jan2016

Study startup times can stifle clinical trials, but automating certain processes can help eliminate costly bottlenecks.

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Study Startup: New Battleground in CRO Differentiation Strategy

by Craig Morgan
11Jan2016

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.

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Disruptive Technologies: Breaking Down Barriers to Drug Development

by Sujay Jadhav
04Jan2016

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.

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Stumbling seven times but recovering eight (Part 2)

by Jae Chung
28Dec2015

Insights for Pharma Executives Sourcing Global Clinical Trials in the US and Japan. This blog is the second part of a two part series.

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Stumbling seven times but recovering eight (Part 1)

by Jae Chung
21Dec2015

Insights for Pharma Executives Sourcing Global Clinical Trials in the US and Japan. This blog is the first part of a two part series.

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"Rescue" studies: The importance of getting clinical trials off to a good start

by Craig Morgan
14Dec2015

Clinical trials are not for the faint of heart, conducting even one clinical trial is a monumental task. Many issues can arise during the course of a clinical trial that can negatively affect a study timeline, which in turn delays regulatory filing, and can ultimately delay market entry.

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goBalto chosen by ICON for all global studies

by Jae Chung
09Dec2015

goBalto Activate chosen by ICON for global site activation, automation and process improvement. ICON implements Activate to accelerate study startup by reducing manual processes.

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10 reasons you'll fall short using Excel for clinical trials

by Craig Morgan
07Dec2015

Regrettably, Excel is still omnipresent in clinical research.

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Challenges to patient data anonymization

by Sujay Jadhav
30Nov2015

In my last blog, I suggested that data anonymization for secondary use is potentially a major barrier to leveraging Big Data from clinical trials.

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Is HIPAA a barrier to Big Data in Biomedical Research?

by Sujay Jadhav
23Nov2015

The vast amount of data generated each day in healthcare represents numerous opportunities to enable the life science research community to access, manage, and implement big data.

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Effective differentiation, the competitive edge for CROs in Study Startup

by Craig Morgan
16Nov2015

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.

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Global Study Startup Survey Reveals Majority of Life Science Companies Lack Automated Processes

by Sujay Jadhav
12Nov2015

Industry leaders are adopting ‘best of breed’ applications in eClinical stack to speed clinical trials.

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Sponsor seeks compatible CRO: Improving Oversight

by Craig Morgan
09Nov2015

Sponsors are embracing outsourcing of clinical trials to contract research organizations (CROs) in order to contain operational and infrastructure costs, as well as gain access to therapeutic and clinical trial expertise, with the potential to complete projects better, faster and more efficiency.

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How pharma can fix its drug development woes by taking a page from the digital marketing playbook

by Sujay Jadhav
05Nov2015

Drug companies should leverage lessons from digital marketing to solve a big, lesser-known issue in drug development.

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Powerful visualizations empower business intelligence in Clinical Trials

by Craig Morgan
02Nov2015

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.

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The Need for Expediency in European Clinical Trials

by Craig Morgan
29Oct2015

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.

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Unmasking Study Startup knockoffs: Big on promise, short on delivery

by Craig Morgan
26Oct2015

Is your study startup (SSU) solution masquerading as a purpose-built application? Often disguised as wolves in SSU clothing, SSU knockoffs fail to live up to expectations.

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Webinar: Ready to start your clinical trial? Think again.

by Craig Morgan
22Oct2015

Save your seat for this upcoming webinar! Listen to our panel of industry experts talk about the importance of getting clinical trials off to a strong start and have your questions answered.

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Role based document exchange facilitates efficient process optimization

by Craig Morgan
19Oct2015

In a previous blog post "The importance of Standard Operating Procedures (SOPs) in clinical trials" the automation of SOPs for document exchange for managing compliance obligations, amongst other performance benefits, was discussed.

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Country specific regulatory workflows streamline clinical operations & compliance

by Craig Morgan
12Oct2015

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.

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Accelerating clinical trial startup with latest goBalto Activate release

by Jae Chung
06Oct2015

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.

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The importance of Standard Operating Procedures (SOPs) in clinical trials

by Craig Morgan
05Oct2015

Standard Operating Procedures (SOPs) are one of the most useful systems to help improve the efficiently of clinical trials, which can aptly be described as "writing down what you do, and do what is written down." 

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Q&A: Mush, you huskies!

by Lloyd Dunlap
28Sep2015

Drug Discovery News editor interviews Sujay Jadhav, goBalto's CEO on the company, products and future plans.

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Go and Balto steal the show at DPharm

by Craig Morgan
21Sep2015

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.

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Expediting Study Startup Across the Globe

by Craig Morgan
14Sep2015

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.

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CTMS - a poor choice for study startup

by Rob Wynden
08Sep2015

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.

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E-Signatures: The Unsung Hero of Clinical Trial Expediency

by Pem Guerry
04Sep2015

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.

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goBalto joins Society for Clinical Research Sites as Global Impact Partner

by Craig Morgan
31Aug2015

Partnership bolsters collaboration with clinical research sites.

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Excel: If all you have is a hammer, everything looks like a nail

by Craig Morgan
24Aug2015

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.

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Opening Pandora's box: The transparency of Clinical Trial data

by Barry Milton
17Aug2015

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.

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Technology trends impacting Clinical Trials

by Ed Miseta
10Aug2015

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. 

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Are you an industry leader or a laggard in Study Startup?

by Craig Morgan
05Aug2015

Advanced, cloud-based collaboration platforms allow sponsors, CROs, and sites to dramatically reduce study startup timelines, eliminate bottlenecks, and reduce costs.

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The need for speed in Study Startup (Part 2)

by Craig Morgan
27Jul2015

Streamlining SSU

The clinical trial landscape is ripe for bringing substantial improvements to the SSU process.

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The need for speed in Study Startup (Part 1)

by Craig Morgan
20Jul2015

The status of clinical trials continues to stymie industry stakeholders anxious to rein in the cost of product development and adhere to tighter timelines. 

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New release of goBalto Activate enhances risk management in Clinical Trials

by Jae Chung
13Jul2015

Industry standard in clinical study startup adds robust project management and business optimization features

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goBalto triples sites managed, further reinforcing market leadership position

by Jae Chung
06Jul2015

Rapid adoption of award winning study startup solutions drive market penetration in Life Sciences industry

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Become a disruptive leader in Clinical Trials and lead the competition

by Craig Morgan
30Jun2015

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. 

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Traversing the user journey

by Tammy Coombs
24Jun2015

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.

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goBalto congratulates the DIA prize winners

by Jae Chung
22Jun2015

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.

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How to conduct a successful usability session

by Tammy Coombs
15Jun2015

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?

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Speeding Clinical Trials Through eClinical Systems

by Elvin Thalund
11Jun2015

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.

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Collaboration is the keystone as the pace of outsourced Clinical Trials accelerates

by Craig Morgan
08Jun2015

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.

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Trusted Collaboration

by Sandra Freeman
04Jun2015

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.

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The Achilles heel of clinical trial study startup—Bottlenecks

by Craig Morgan
01Jun2015

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).

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An attitude for CAN

by Craig Morgan
28May2015

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."

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Moving beyond simple APIs in the eClinical Stack

by Craig Morgan
26May2015

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).

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Globalization of clinical trials increases complexity in oversight

by Craig Morgan
21May2015

As clinical trials increasingly are conducted outside the US, Pharma and CROs face both opportunity and challenge especially in emerging markets.

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Gartner recognizes goBalto as a "Cool Vendor in Life Sciences"

by Craig Morgan
19May2015

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."

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Eliminating the three evil "e's" from Study Startup

by Craig Morgan
15May2015

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.

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For faster study startup eTMF alone won't cut it

by Rob Wynden
08May2015

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.

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What differentiates goBalto from an eTMF?

by Rob Wynden
02Apr2015

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.

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No, eTMF can’t do study startup – despite what you’ve heard

by Rob Wynden
19Mar2015

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.

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Using Technology to Improve Study Startup

by Roshan Padbidri
22Oct2014

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.

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Usability in Action

by Tammy Coombs
25Mar2014

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.

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Designing the Experience

by Steve Winter
13Feb2014

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.

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Patient Recruitment (Again)

by Blake Reuter
22Aug2013

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.

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Investigators’ Main Complaint: Study Site Payment Schedules

by Blake Reuter
07Aug2013

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.”

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What Are the Top Three Items Used to Select Sites? ...And What Should They Be?

by Sherry Reuter
27Mar2012

A frank discussion about studies

An interesting discussion has taken place over the last month on LinkedIn in the The Association of Clinical Research Professionals group (view discussion here).

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Source Document Verification - How much is enough?

by Sherry Reuter
23Feb2012

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.

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Where does the name goBalto come from?

by Jae Chung
16Nov2011

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.

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The Site’s Side: Patient Recruitment

by Sherry Reuter
04Oct2011

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.

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Clinical Regulatory Documents: Master of your TMF Domain

by Swadesh Sharma
28Sep2011

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.

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What Has Your Clinical Trial Management Platform Done For You Lately?

by Todd Tullis
19Apr2011

When selecting a technology platform for management of clinical trials, study sponsors face more than a few potentially costly decisions & tradeoffs. The first challenge in selecting a technology (or technologies) is understanding one’s options - the wide scope of operations supported by various vendor systems can make comparing two systems difficult.

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Do you use Excel to track site activation? Then this article was written just for you!

by Jae Chung
30Mar2011

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.

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The Correct Way to Start a Clinical Trial in 10 Steps

by Jae Chung
22Dec2010

So here it is folks! In early 2010, goBalto started its highly acclaimed "10 Steps to Clinical Study Start Up" series on our blog - the Chromosome. We believe that the existing approach to starting clinical studies is way too cumbersome.

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10 Steps to Clinical Study Start Up: Step 10 - Wrap Up

by Jae Chung
26Oct2010

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!

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10 Steps to Clinical Study Start Up: Step 9 – Preparing Regulatory Documents

by Jae Chung
28Sep2010

This is the 9th installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Start Up: Step 8 - Investigator Meetings

by Jae Chung
17Aug2010

This is the 8th installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Start Up: Step 7 - Negotiating the CTA

by Jae Chung
14Jul2010

This is the seventh installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Start Up: Step 6 - The Clinical Trial Agreement (CTA)

by Jae Chung
23Jun2010

This is the sixth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Startup: Step 5 - The Pre-Study Visit (PSV)

by Jae Chung
09Jun2010

This is the fifth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Startup: Step 4 - Sending, Tracking, and Evaluating SFQs

by Jae Chung
26May2010

This is the fourth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Startup: Step 3 - Sending CDAs to Sites

by Jae Chung
12May2010

This is the third installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Startup: Step 2 - How to send requests to investigative sites

by Jae Chung
28Apr2010

This is the second installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 Steps to Clinical Study Startup: Step 1 - How to identify qualified sites

by Jae Chung
21Apr2010

This is the first installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

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10 steps to Clinical Study Startup

by Jae Chung
06Apr2010

We all know managing studies are challenging. However, how much thought do you give to improving the startup phase, where much of the critical groundwork is being laid? If you're like most folks we've spoken to, you've accepted that the study startup is done through, phone, fax, email and excel spreadsheets. Too complex! Too manual! Too inefficient!

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