Electronic Trial Master File (inc. Electronic Archiving)
key details
| Value | £135,000 |
|---|---|
| Status | complete |
| Category (CPV) | 48814000 +5 more |
| Deadline | 28 Jun 2024 |
| Contract start | 7 Mar 2025 |
| Contract end | 6 Mar 2028 |
| Procedure | open |
| SME suitable | Yes |
| OCID | ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044 |
Award
| Supplier | Value | Date | Status |
|---|---|---|---|
| Cognidox Limited | £135,000 | 7 Mar 2025 | active |
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 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.
documents
- https://www.contractsfinder.service.gov.uk/Notice/018e45ed-5dca-4435-aaee-b74b65e444f0 , tenderNotice
Documents are linked, not mirrored. They are served by the publishing authority and may require registration.
notice history
2 notices published against this procurement.
| Published | Type | Regime | Notice |
|---|---|---|---|
| 28 May 2024 | Tender amendment (tenderAmendment) | · | 018e45ed-5dca-4435-aaee-b74b65e444f0-754645 |
| 7 Mar 2025 | Award (award) | · | c2a3a395-5e64-44bb-9858-49b1acb5cb0f-832522 |
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source
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