Taking the Right Approach to Data Integrity in Rescue Studies
Nancy Bates • December 15, 2022 • 1 min. read
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
Nancy Bates is an Associate Director of Data Management at Precision for Medicine with over 20 years of data management experience, having worked in both the CRO and pharmaceutical space. She has successfully managed Data Management projects for many programs and excels at process analysis and process improvements. As a leader, she is a champion for her team members, helping to train and support them as they progress in their careers.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.