Successful trial master file management involves preparing for regulatry audits. Anticipating and preparing for upcoming regulatory inspections can be a difficult undertaking for life science organizations. In some circumstances, companies expect regulatory agencies’ visits. For example, life science teams that have recently launched a new product may undergo an inspection within two years of product launch.
In other situations, a regulatory inspection may occur without warning. A senior vice president at one biotech company explained that business development deals often prompt a surprise visit from regulators. In her experience, regulatory authorities may conduct an inspection between three and six months after acquisition or merger deals are finalized. These visits help regulators assess how well companies have integrated their respective standard operating procedures (SOPs).
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
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
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
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
When it comes to clinical outsourcing practices, many pharmaceutical and device teams partner with third-party solution-providers to supplement existing, in-house expertise. Contract research organizations (CROs) support clinical activities in a number of fashions. Continue reading