How To Establish Effective, Scalable Drug Safety Ops Across Multiple Vendors

By Rosa Lee Smith and Raul P. Lima, inSeption Group, and Elizabeth Delmaestro, Independent Consultant

Often, the catalyst for safety program issues —most commonly, non-compliance with safety reporting regulations — is the use of multiple safety vendors., A combination of strategies and tools can help navigate the challenges that arise from contracting multiple safety vendors within one or more investigational medicinal product (IMP) development programs.

A trio of strategies can help sponsors to overcome disparate data listings and formats. First, sponsors can share data formats/templates during implementation/onboarding of each safety vendor to ensure alignment. Second, sponsors should establish a standard onboarding process for new safety vendors. Third, sponsors should attempt to contract a central safety vendor for all studies or use multiple vendors who utilize the same safety system.

In short, problems are on the horizon if clinical operations, safety vendors, and, to some extent, regulators are not having early and frequent conversations about drug safety and how it will come together holistically.