Electronic Trial Master File (inc. Electronic Archiving)
Details
| Contract Title: | Electronic Trial Master File (inc. Electronic Archiving) |
| Published Date: | Mar 11, 2025 |
| Notice Type: | Award (CompetitiveContractAwardNotice) |
| Value Banding: | Low Value |
| Delivery Point: | United Kingdom |
Description:
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 regulato...