Supply of Electronic Trial Master File and Archiving Solution to University of Southampton
UNIVERSITY OF SOUTHAMPTON · Awarded contract
AwardedSupply of Electronic Trial Master File and Archiving Solution to University of Southampton
Awarded 07 Mar 2025
Expires in 1y 4mo3y term, 56% elapsed
Awarded 7 Mar 2025Expires 6 Mar 2028
About
University of Southampton awarded a contract to Cognidox Limited for an electronic Trial Master File (eTMF), electronic Investigator Site File (eISF), and eArchiving solution for the Southampton Clinical Trials Unit (SCTU).
The solution meets regulatory requirements, including Eudralex Vol4 Annex 11 for computerised systems, and follows ALCOA+ principles.
It supports regulatory-compliant e-signatures and ensures data and metadata retrievability for up to 30 years.
The SCTU expects 4-6 new trials annually and 25 trials recruiting at any one time.
The contract value is £135,000.
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Supply of Electronic Trial Master File and Archiving Solution to University of Southampton
Won by Cognidox Limited · UNIVERSITY OF SOUTHAMPTON
£135Kawarded
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