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Taking the Right Approach to Data Integrity in Rescue Studies

Right Approach to Data Integrity

Bringing your study’s success back on track

When a clinical trial runs into difficulties, bringing in a “rescue” CRO can be a complex and daunting task. However, with careful planning and clear communication, the transition can be smooth and successful. Bringing in a rescue CRO to take over a clinical trial requires careful planning and clear communication to ensure that data integrity is preserved, and data management responsibilities are efficiently transferred:

  • Establish clear communication between the sponsor and the lead data manager of the incoming CRO
  • The incoming CRO should develop a transition plan and timeline during a formal kickoff meeting
  • Decide on an approach for transferring the database to the incoming CRO

While rescue studies face a number of challenges, the right planning can support a smooth and successful transition. To learn more about Protecting Data Integrity when transitioning to a new CRO, read the full publication in Applied Clinical Trials.