Achieving And Maintaining Sponsor Oversight Of Outsourced Studies

By Marion Mays

Regulators have made it abundantly clear, through recent guidance and inspection findings, that compliance responsibility for an outsourced trial lies with the sponsor – and not the service provider. During an inspection, agencies will review the TMF for clear evidence of ongoing and effective trial oversight by the sponsor. Along with the all-important components of quality, completeness, and timeliness, demonstrating oversight is a critical requirement for TMF health and inspection-readiness.

With the operational outsourcing of clinical trials increasing, however – and with trials producing more documentation, from different sources and in different formats – conducting effective oversight has become increasingly challenging. Both sponsors and CROs struggle with information overload and time-consuming manual processes in determining what’s important from a TMF standpoint.

To achieve your goal of compliance best practices around oversight, it’s helpful to review what aspects inspectors will look for in the TMF when establishing sponsor compliance with oversight requirements. Among other items, regulators will assess the presence (or absence) of the following: