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EZEN offers a wide range of TMF-related services, supported by a unique combination of clinical trial knowledge, document management skills, regulatory understanding, and technical expertise.
Trial Master File Quality Control (TMF QC) is carried out by our team of trained and experienced individuals who check the TMF documentation at several key stages through the clinical trial process, often upon receipt of documents and pre-archive, at the Sponsor site, the Contract Research Organization (CRO) site or EZEN offices.
This high-level check is to ensure artefacts are accounted for (present or absent) in the TMF. The general standard of filing, including accuracy and reverse date ordering, is also checked. The output of Level 1 QC is a summary checklist detailing artefacts with missing documents.
Includes high-level section checks as defined in Level 1, including document quality checks for dates, signatures, versions, and completeness and cross- checks to ensure associated documents are present and complete. The output is a series of reports based on the TMF structure per trial, country, or site, allowing the data and findings to be assessed and presented in a variety of ways.
This includes section and document level checking, as defined in Level 2, including a further review of documents and processes to check for compliance and oversight. The output is a comprehensive report customised to your requirements.
EZEN’s experience with TMF and eTMF requirements from a Regulatory Authority perspective is unmatched.
Our team of experienced document experts and consultants will help you prepare your TMF ahead of inspection through a selection of services offered at the sponsor site, Contract Research Organization site (CRO), the investigator site, or our offices. EZEN can help clients prepare their TMF through a variety of services: