Electronic Trial Master File (inc. Electronic Archiving)
UNIVERSITY OF SOUTHAMPTON · awarded 7 March 2025
Who
| Buyer | UNIVERSITY OF SOUTHAMPTON SOUTHAMPTON |
|---|---|
| Supplier |
Cognidox Limited |
| Category | services |
| Classification | Medical information systems CPV 48814000 |
| Notice published | 7 March 2025 |
What it is for
The Southampton Clinical Trials Unit (SCTU) requires an electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) and eArchiving solution that meets regulatory requirements (including Eudralex Vol4 annex 11 for computerised systems). These solutions should follow the ALCOA+ principles (Attributable, legible, contemporaneously recorded, original or a true copy, accurate, complete, consistent, enduring, and available). Documents should be able to be approved with fully regulatory compliant e-signatures. The University requires data to be retrievable, along with all metadata, for up to 30 years. The SCTU expects 4-6 new trials a year, and 25 trials recruiting at any one time.
Read the original award notice on Contracts Finder →
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Other contracts won by this supplier
1 award on file, worth £135k.
| Awarded | What for | Buyer | Supplier | Value |
|---|---|---|---|---|
| 7 Mar 2025 | Electronic Trial Master File (inc. Electronic Archiving) | UNIVERSITY OF SOUTHAMPTON | Cognidox Limited | £135k |