PRC Clinical Case Study: Rescue Project From U.S. CRO
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Case Studies //
PRC Clinical Case Study: Rescue Project From U.S. CRO
OVERVIEW
PRC Clinical successfully executed a critical rescue project for a global clinical trial: 10 countries and 57 sites. This achievement underscores PRC Clinical’s expertise in clinical trial management and operational excellence.
KEY ACHIEVEMENT
PRC Clinical seamlessly transitioned responsibilities from a U.S.-based CRO that ceased operations and integrated documentation from the ex-U.S. CRO into its Veeva eTMF system, ensuring compliance and timely outcomes.
STUDY DETAILS
- Indication: Global regulatory compliance and document management
- Study scope: Rescue project spanning 10 countries and 57 sites
- Document volume: 27,600 uploaded and 24,500 quality checked
CHALLENGES ADDRESSED
- U.S. CRO closure: Ensuring continuity of operations following the closure of the U.S.-based CRO.
- Global document integration: Streamlining documents from the ex-U.S. CRO into PRC’s Veeva eTMF.
- High document volume: Managing 27,600+ documents, with 24,500 requiring QC.
- Data gaps: Addressing missing feasibility trackers, IRB approvals and protocol amendment training.
- Inspection readiness: Preparing inspection-ready documents under tight timelines.
STRATEGIES IMPLEMENTED
- Proactive planning: Ensured all stakeholders were informed of timelines and milestones well in advance
- Efficient transition: Seamlessly took over from the U.S. CRO, maintaining continuity and compliance
- Collaborative engagement: Worked with ex-U.S. CRO and sponsor to collect and reconcile missing documents
- Technology integration: Leveraged Veeva eTMF to unify and streamline documentation
RESULTS
- Regulatory excellence: Unified documentation into PRC Clinical’s Veeva eTMF, achieving compliance for 10 countries and 57 sites
- Operational efficiency: Seamlessly resolved challenges associated with the CRO transition
- Enhanced inspection readiness: Prepared over 27,600 documents for review, meeting all compliance requirements
CONCLUSION
PRC Clinical’s proactive approach ensured a smooth rescue transition for the sponsor’s clinical trial. By taking over from the closing U.S. CRO and integrating ex-U.S. CRO documentation, PRC Clinical delivered a unified and inspection-ready TMF on time. This achievement highlights PRC Clinical’s ability to manage complex global studies with precision and collaboration.
