Right-Size Risk-Based Monitoring Activities by Evaluating Individual Site Data

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Senior Research Analyst

Risk-based monitoring is a highly individualized practice among life sciences companies.  Each organization’s clinical trial team may have a different threshold of risk with which they are comfortable.  Teams also employ different mixtures of remote and centralized monitoring techniques. As such, firms must continually evaluate incoming data for factors that indicate a need for increased risk-based monitoring activities. Continue reading


Clinical Outsourcing Decision-Making at a Glance

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

To provide continuous support throughout the product development process, life science companies may seek additional assistance from third-party solution-providers. Research and development (R&D) teams may lack necessary in-house capabilities—be it limited staffing or insufficient technology—to fulfill their preclinical and clinical trial needs.  For example, not all companies have full service labs in-house.  Consequently, these organizations look to clinical outsourcing options for diagnostic or other test types.  Continue reading


Determining Trial Master File Management Staffing Levels

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

The trial master file (TMF) incorporates every aspect of a clinical trial, so TMF management will similarly include people from all parts of a clinical trial’s operations.  These groups include everyone from clinical development to data management, regulatory affairs and contract management — just to name a few.  Cutting Edge Information’s report about TMF management collected benchmarks for the number of FTEs responsible for TMF from different groups. Continue reading


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