Effective electronic Trial Master File (eTMF) management is essential to the success of clinical trials, ensuring regulatory compliance, operational efficiency, and the integrity of trial data. Serving as the blueprint of a study, the eTMF documents and supports all decisions made throughout a trial. As clinical research evolves, the role of the eTMF will remain pivotal in maintaining the highest standards of quality and supporting innovation. 

In addition to comprehensive global records management services, Premier offers comprehensive eTMF reviews, migration support, and debarment check strategy. Our eTMF specialists conduct comprehensive quality reviews—both ongoing and retrospective—to keep your trial inspection ready. Our meticulous remediation process is collaboratively managed across Sponsors, CROs, and vendors, ensuring alignment and efficiency.

Over the past five years, Premier has conducted more than 25 comprehensive quality reviews, including global, multi-country reviews and hundreds of sites. With expertise across leading eTMF platforms—including Trial Interactive, Veeva Vault, Wingspan, and Innov—Premier is uniquely positioned to support organizations in optimizing their eTMF strategy for regulatory success.

Our Approach to eTMF Quality Reviews

Premier’s eTMF quality reviews go beyond system checks. We implement a structured, GCP-based methodology that includes both standard and customized logic checks and strategic remediation. Our process includes:

• Scheduled Rolling Reviews: Conducted at 6-month intervals or at key study milestones 
• Customized Study-Specific Guidance: A tailored blueprint supporting efficient, cost-effective documentation reviews at study, country, and site levels. 
• Cross-Functional Collaboration: Engaging sponsor, CRO, and vendors to ensure alignment

Our review takes into consideration the following key documents, so that all study specific nuances are captured during the review process:

• TMF Management Plan and corresponding TMF Index
• Project Management Plan
• Clinical Monitoring Plan
• Data Management Plan
• Safety Management Plan
• Statistical Analysis Plan
• Central IRB Portal, as needed
• Pharmacy Manual and relevant SOPs, as needed

By leveraging all available materials and collaborating closely with stakeholders, we identify gaps and risks to provide thoughtful and timely remediation strategies to support an inspection-ready TMF.

By keeping your eTMF inspection ready, you can be confident that all study collaborators—CROs, sites, and vendors—are also inspection ready. If you have any questions about eTMF quality review, contact Premier’s team of experts to explore the best path forward.  

eTMF Migration

Most organizations invest significant time and money developing their clinical programs in anticipation of regulatory submissions. However, as sponsors prepare for NDA submission, they often discover that their eTMFs are fragmented across multiple partner CROs using various platforms. This lack of centralization makes inspections more challenging, increasing the risk of quality issues and inefficiencies. 

The solution is to migrate and centralize your eTMFs under one single platform with a dedicated partner. A streamlined, centralization system—managed by an experienced team—ensures inspection readiness.

Premier’s experts can assist with:

• Migrating paper TMF or eTMF systems post-study
• Strategically centralizing files at the beginning of your development journey
• Ensuring all documents are easily accessible and compliant

If you’re considering TMF migration, our experts are here to guide you. Contact Premier today to explore the best strategy for your organization.

Debarment Checks

Have you confirmed that debarment checks have been completed for all site staff—not just the PI? Filing debarment checks in the eTMF helps ensure that no individuals barred by regulatory authorities, especially the FDA, are involved in your clinical study. These checks are often overlooked and frequently addressed late in the study, creating serious documentation gaps and potential quality issues.

At Premier, we’ll thoroughly review your process to ensure all required documentation is complete and compliant, ensuring a strategy for timely debarment checks—typically at study startup, prior to site initiation.

Don’t let uncertainty around debarment checks compromise your study. Contact Premier today to discuss your program.