At Premier Research, our Global Records Management team provides comprehensive Trial Master File (TMF) services that are seamlessly integrated into your clinical trial or provided as a standalone solution, designed to fit the needs of your clinical program. With dedicated records management professionals across the United States, United Kingdom, Poland, Romania, Bulgaria, and India, we offer flexible, scalable support tailored to your needs.

With a proven track record, we have managed hundreds of clinical trial TMFs across all phases, sizes, countries, and therapeutic areas. Whether you need end-to-end TMF management, ongoing compliance support, or expert guidance for audits and inspections, we provide a turnkey approach that ensures regulatory readiness and operational efficiency.

Whether you need TMF setup, ongoing management, quality reviews, or archiving, we provide a turnkey approach backed by our global TMF Standard Operating Procedures (SOPs) and the CDISC TMF Reference Model.

Expert-Led TMF Oversight and Compliance

Our Global TMF Leads serve as subject matter experts, offering:

• Project and program-level TMF management – Tailored TMF plans and indexes.
• Regulatory inspection readiness – Conducting gap analysis and remediation to ensure compliance.
• Audit and compliance support – Representing TMFs in KOMs, audits, inspections, and team meetings.
• Process and system training – Educating teams on best practices and regulatory requirements.
• Performance tracking and oversight – Reporting TMF KPIs, ensuring ALCOAC compliance, and streamlining TMF submission, delivery, and archiving.

eTMF Expertise Across Multiple Platforms

Premier Research is system-agnostic, with experience in all major eTMF applications, including Trial Interactive™, Veeva Vault, Wingspan. We offer full administrative capabilities and licensing for these platforms, eliminating the need for third-party vendors.

Seamless eTMF Access and Management

Our industry-leading SaaS eTMF solutions provide:

• Unlimited user accounts and unrestricted access to studies and content volume.
• 24/7 global access to all active and archived TMFs in a single system.
• End-to-end TMF lifecycle management – From setup to archiving with harmonized indexing and standardized processes.
• No vendor management hassles – We handle eTMF selection, qualification, validation, contracting, and system administration for you.

Why Choose Premier Research for Records Management?

• Proven Experience – Managing hundreds of TMFs across diverse therapeutic areas and trial sizes since 2012.
• Global Reach, Local Expertise – Dedicated TMF professionals across multiple regions for international regulatory alignment.
• Technology-Driven Efficiency – Expertise across Trial Interactive™, Veeva Vault, and Wingspan ensures seamless eTMF integration.
• Regulatory Confidence – Inspection-ready TMFs with comprehensive gap analysis and remediation strategies.

With Premier Research, you gain a trusted, scalable, and fully compliant partner for global TMF management. Contact Premier today to discuss the best way to approach TMF management for your unique project.