When sponsors choose to outsource all or certain tasks of a clinical trial to a clinical research organization (CRO), the relationship becomes critical. Since CROs have their own processes, it is critical to define what deliverables will be expected and how quality will be measured before the study begins.

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How to partner with your CRO for a successful end-of-study transfer

4 collaboration considerations to achieve high-quality, regulatory-compliant TMF

When sponsors choose to outsource all or certain tasks of a clinical trial to a clinical research organization (CRO), the relationship becomes critical. As such, it should act as a partner, not a vendor. The CRO directly supports the health of your trial by generating evidence, collecting data and transferring information at the end of a study. Since CROs have their own processes, it is critical to define what deliverables will be expected and how quality will be measured before the study begins.

1. Create a cohesive partnership between sponsors and CROs

A partnership between a sponsor and a CRO is only as strong as the operating model that defines it. To avoid friction throughout a contract, both parties should reach a consensus about what metrics bear significance, what level of missing content is acceptable, and how often reports should be delivered. Additionally, decide how closeout activities will be documented and supported. Once metrics are solidified, set timelines for reporting on this data and ensure that all parties agree on these timelines before the trial begins. Identify and agree on metrics to measure quality; missing documents should be monitored and any critical documentation should be addressed before study closure. For example, your CRO should provide evidence that they have conducted due diligence for any missing data or documents.

2. Use data to design and define a transparent collaboration process

A well-designed system can help sponsors work more effectively with CROs. Reliable, robust systems can ensure that everyone is on the same page and simplifies an otherwise complex process. Clinical operations, data management, and pharmacovigilance teams must...

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