Please Treat Me Better Than the Mice.
Here at Cutting Edge Information, we spend a lot of time researching how companies take products from pre-clinical through approval and then support those products once they reach the market. But sometimes a change in perspective is good. So a few weeks ago I enrolled in a Phase 1 clinical trial to see what the process looks like from the patient’s side. While I cannot go into great detail about the specific processes around the trial, I did have some observations for the industry that we all work in. Continue reading
Managing trial master files (TMFs) is more than an administrative function. Even so, convincing internal teams of the substantive value that TMF functions provide is a challenge that many surveyed life science teams face. The earlier that companies can prioritize TMF activities, the less likely they are to incur problems during future regulatory inspections. Continue reading
Clinical trial monitoring – or risk-based monitoring (RBM) – 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
Outsourcing clinical trials is a key decision that every pharmaceutical company will have to make at some point. 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
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
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
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
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
Quality control (QC) is certainly an important aspect of companies’ trial master file (TMF) activities. Compiling and reviewing TMF document quality early is the first step for TMF teams looking to reduce their quality assurance-induced headaches. However, another important consideration is determining which materials will undergo review—and how frequently.
From clinical development to product launch, TMF document 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