FDA
Findings for record keeping and record retention.1
Modernize Trial Master File Processes
Implement sponsor-owned eTMF and continue to outsource to CROs,
increasing inspection readiness and conserving resources.
Regulatory Expectation for Sponsor eTMF
During inspections, regulators expect access to an eTMF system with full documentation of the trial's history. Major agencies’ annual reports reveal documentation-related findings:
MHRA
Significant findings for missing and misplaced essential documents and audit trail issues.2
EMA
Highest number of findings for recordkeeping, essential documents, and data integrity.3
Findings can result in:
Costly processes to correct
Lost revenue
Commercialization delays
Why Sponsors Implement eTMF
As new inspection and trial approaches gain ground, now is an ideal time to implement an electronic TMF system to improve inspection readiness and reduce trial timelines.
How to Implement a Strategic eTMF Model
More sponsor companies are implementing a hybrid governance eTMF model to drive inspection readiness while conserving resources. In this model, sponsors manage a subset of documents in their eTMF, while CROs maintain the majority of trial documentation and transfer it to the sponsor at the end of the study.
Read case study
Alvotech Fast-Tracks Compliance with Sponsor eTMF
Read case study
OM Pharma Drives TMF Inspection Readiness with a Lean Team
Read guide
Sponsors Share How To Select an eTMF Operating Model
Streamline Processes with eTMF
Building the Business Case for Sponsor eTMF
Cancer Research UK built a business case to transition from paper to eTMF, focusing on three areas: cost-effectiveness, improved quality, and process efficiencies.