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Our dedicated specialists deliver proactive eTMF setup, maintenance, and oversight, ensuring
a seamless process from study initiation to close-out. We manage every aspect of the document life cycle — from controlled creation and version tracking to quality review and archiving — so that your eTMF meets the highest standards of data integrity and traceability.

We are experienced across a range of electronic document management systems and provide particular expertise in the Viedoc eTMF platform, helping sponsors and CRO partners configure, operate, and maintain efficient eTMF environments that meet both sponsor and regulatory expectations.

Our eTMF services include:

• Rapid eTMF setup and configuration tailored to protocol and sponsor requirements

• Lifecycle tracking for every essential document, ensuring real-time visibility of completeness and status

• Multi-level quality checks to maintain document accuracy, integrity, and alignment with ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate)

• Continuous performance monitoring of eTMF metrics such as completeness, timeliness, and document quality

• Issue identification and resolution, addressing eTMF challenges promptly to prevent inspection findings

• Audit and inspection support, ensuring your eTMF is fully compliant and ready for MHRA, EMA, or FDA review

Why choose Niche Science & Technology

Our active eTMF management approach is designed to minimise risk and maximise compliance. We don’t just file documents — we manage them as living records of your clinical study, ensuring transparency, consistency, and regulatory alignment.

With over 25 years of experience supporting biotech and pharma clients, Niche combines deep regulatory understanding with agile delivery. Partnering with us gives you confidence that your eTMF and clinical trial documentation are managed with precision, professionalism, and complete regulatory readiness.