Recent decades have seen a rapid escalation in the complexity of clinical trials. Regulatory demands for greater safety and efficacy data have required late stage (Phase III) trials involve significantly higher patient enrollment. Additionally, many late-stage drug development programs consist of multiple large scale trials, assessing the drug candidate in different patient populations across a wider geography.
Each of these trials typically requires a broad range of ancillary materials (e.g. equipment, instruments, and consumables) in addition to the Investigational Medicinal Product (IMP). Investigator sites are not typically equipped to locally source and store these materials without support from the trial sponsor. At the same time, managing the procurement, storage and distribution of these ancillary materials for large, multi-country trials can result in an administrative burden that is beyond the sponsor’s capacity.
This eBook analyzes the effect of the current industry trends on the clinical ancillary market. It offers suggestions for effectively planning an ancillary supply strategy and tips on execution techniques will help to ensure that your company’s current workload is minimized without derailing your critical research. Key industry challenges that clinical trial team’s face when managing ancillaries will be reviewed and pragmatic solutions presented.