Leverage Centralized Risk-Based Monitoring Tactics to Preserve Data Quality and Highlight Potential Problem Areas

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Since its inception in 2012, the industry group TransCelerate has developed many clinical initiatives, from clinical data standards to site qualification and training.  Each of these ongoing programs is aimed at improving research and development practices across the biopharmaceutical industry.  The group’s risk-based monitoring initiative—also launched in 2012—aims to help life science teams maximize site monitoring outcomes by developing site visit schedules based on potential trial risk.  Continue reading


Life Science Teams’ Use of Electronic TMF Components Remains on the Rise

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

In 2015, Cutting Edge Information researched how global and country-level life science teams balance paper-based and electronic documents within their trial master files (TMFs).  So far, global teams report the highest percentage of electronic trial master file documents within their TMFs.   Currently, life science teams at the global level report TMFs that are an average of 54% electronic and 46% paper.  By comparison, surveyed US teams report only 38% electronic trial master files, on average.  Continue reading


Balancing Clinical Trial Planning and Execution Activities: The Growing Importance of the CRO

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

According to clinical outsourcing research conducted earlier this year, life science teams report varying levels of CRO involvement in their clinical studies. Often, companies seek CRO expertise on the trial execution side of clinical operations.  As shown below, surveyed pharmaceutical and device teams outsource an average of 68% of their data management workloads and 60% of their clinical operations workloads (Figure 1).  Surveyed teams also outsource relatively high percentages of other execution-based activities as well.  For example, surveyed pharmaceutical and device companies outsource an average of half of their non-risk-based trial monitoring activities and roughly 44% of their drug safety duties. Continue reading



Upholding TMF Document Quality Part One: Initiate Quality Control Activities Early to Avoid Herding Cats

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

From clinical development to product launch, TMF quality control activities remain an important consideration for life sciences teams.  In the wake of drug supply chain interruptions, many companies have taken increased care to uphold the integrity of their manufacturing and drug delivery processes to assure patient safety.  But, what about upholding the quality of the clinical trial documents that not only help companies’ products receive marketing clearance but also effectively outline products’ development pathways? Continue reading


Risk-Based Monitoring Ownership: Companies Continue to Look to Clinical Operations to Lead the Way

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

If this year’s annual Drug Information Association (DIA) meeting is any indication, risk-based monitoring (RBM) remains a key area of interest for the life sciences industry.   Many companies have embraced RBM practices for some time—albeit, perhaps not labeling it as such.  However, life science teams continue to research the best ways to implement RBM strategies in an effort to conserve trial resources and mitigate rising study costs. Continue reading



TransCelerate Releases New Risk-Based Monitoring Update

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Earlier this summer, TransCelerate Biopharma—a non-profit life sciences group comprised of an array of industry audience types—released its most recent risk-based monitoring update.  In its most-frequently asked section, the group tackles a topic that seems to be on a lot of industry executives’ minds: source data verification (SDV) in risk-based monitoring trials.  Earlier TransCelerate findings indicated that conducting 100% SDV does not necessarily prevent major or critical findings. Continue reading


Informing Patients Doesn’t Stop with Recruitment: One-on-One Patient Engagement Practices Bolster Patient Retention

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Contract research organizations (CROs) play an ever-present role in companies’ clinical trial practices.  Many sponsors leverage these third parties to support study elements like site monitoring and patient recruitment.   Patient recruitment in particular has always been a difficult task for sponsors, CROs and site teams alike.  To help alleviate the challenge of patient recruitment, some CROs are customizing their approach, to ensure that they can both attract qualified study participants and keep these individuals interested throughout the clinical trial. Continue reading


Securing Stable Sponsor-CRO Partnerships: Never Underestimate the Power of Communication

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Contract research organizations (CROs) can offer multiple benefits to sponsors: from helping teams to hone their internal expertise to supplementing in-house staffing and technological capabilities. Some life science teams prefer to leverage CRO partnerships when conducting clinical trials.  Others may reach out to vendor parties to assist in product development well before Phase 1 studies.  Still others may contract with CROs to expedite the manufacturing of active pharmaceutical ingredients (APIs). Continue reading