Trial Master File and 
Document Management

We offer a comprehensive electronic Trial Master File (eTMF) services. We understand the critical role of the TMF in managing and tracking the progress of clinical trials and demonstrating compliance with Good Clinical Practice guidelines and regulatory requirements.

Our team is dedicated to providing exceptional eTMF management services, ensuring your trial runs smoothly from start to finish.

We are experienced with various electronic management systems but provide specific guidance on the use of the Viedoc management system.

Our eTMF services include fast TMF Setup, keeping track of document life cycles, performing quality checks on multiple levels, and resolving any TMF challenges in a timely manner. Our active management approach is addresses all metrics (e.g., completeness, status, document quality, etc.) available for electronic TMFs, with our documents addressing ALCOA principles and being audit

 

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Frequently Asked Questions
We use validated electronic eTMF systems that allow secure, real-time access to study documents. Our team ensures that all TMF documents are audit-ready and comply with industry standards like ICH-GCP and FDA 21 CFR Part 11.
We maintain an organized, complete, and up-to-date TMF throughout the study lifecycle. Regular internal audits are conducted to ensure that the TMF is inspection-ready at any time, with complete version control and metadata tracking.
Our eTMF system is highly flexible and can integrate with your existing document management platforms. We provide customised solutions to ensure a seamless workflow between our systems and yours.

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