Successful CRO Audits to Recover Critical Data
March 10, 2015
Challenge > Short Timeline to Recover Data After Terminated CRO Contract
PRC Clinical was contacted by a US-based sponsor to help them recover critical study data from their previous CRO after their contract was terminated. The sponsor client terminated their relationship with their existing CRO, leaving only 30 days to audit and retrieve study materials from this (now uncooperative) CRO.
PRC Clinical was tasked to quickly created an audit plan, identify and assemble a team of experienced Auditors for specific CRO transition audits in the United States and the United Kingdom simultaneously.
Solution > PRC Clinical Plans and Executes Successful Audits in the US and the UK
PRC Clinical visited the CRO at two sites in the United States and United Kingdom to audit them, and recover the project records on behalf of the sponsor.
Although relations between the sponsor and current CRO had deteriorated, PRC Clinical professional ‘third-party’ approach was very successful in gaining access to the necessary materials and files to conduct a comprehensive compliance audit and data retrieval within the allotted timeline.
PRC Clinical proved its capacity to do anything in its power to ensure a smooth transition for its client, even in a seemingly complex and hostile situation. The team of auditors assembled by PRC Clinical was creative, flexible, and professional.
PRC Clinical Case History > Key Highlights
- Strong responsiveness to audit CRO in 30-day timeline.
- Professional ‘third-party’ approach.
- Successful recovery of critical study data for sponsor.