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| Source: | Contracts Finder |
| Notice Type: | Award notice |
| Buyer: | UNIVERSITY OF SOUTHAMPTON |
| Main Category: | Services |
| Procurement Method: | Open procedure (below threshold) |
| Tender Status: |
| Closed |
| Estimated Value (ex. VAT): | £90,000 |
| Release Date: | 7 March 2025 |
| Application Deadline: | 28 June 2024 |
| Contract Start Date: | 7 March 2025 |
| Contract End Date: | 6 March 2028 |
| Contract Duration: | 3.1 years |
| Procurement ID (OCID): | ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044 |
| Notice Reference: | c2a3a395-5e64-44bb-9858-49b1acb5cb0f-832522 |
All 3 notices for this procurement, oldest first.
Electronic Trial Master File (inc. Electronic Archiving)
Electronic Trial Master File (inc. Electronic Archiving)
Electronic Trial Master File (inc. Electronic Archiving)
Earlier notices predate the Procurement Act 2023 (commenced 24 Feb 2025) and therefore don't carry UK1–UK17 codes.
View Original Notice
Access the full notice on the official portal
Awarded to
| Award value: | £135,000 |
| Award decision date: | 7 March 2025 |
| Award status: | Active |
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.
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Pipeline status
Not addedImports the contract into your BidWriter pipeline · Qualify before you commit to bid
Application Deadline
28 June 2024
Closed
Estimated Value
£90,000
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