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


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