# Electronic Trial Master File \(inc\. Electronic Archiving\)

> Contract award record from UK public-sector procurement sources.

## Key facts

- Public buyer: [UNIVERSITY OF SOUTHAMPTON](/buyers/university-of-southampton/contract-awards)
- Contract winner: Cognidox Limited
- Award value: £135,000
- Tender value: £135,000
- Award date: 7 March 2025
- Published: 7 March 2025
- Contract start: 7 March 2025
- Contract end: 6 March 2028
- Stage: awarded
- Procurement category: services
- Notice ID: c2a3a395-5e64-44bb-9858-49b1acb5cb0f-832522
- OCID: ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044

## 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\.

## Related contract awards

- [English Language Print Books for Library Stock](/contracts/ocds-b5fd17-cdf2db0a-f046-4de7-beff-d85e0c115758): UNIVERSITY OF SOUTHAMPTON
- [Qlik Licences](/contracts/ocds-b5fd17-0feb1a9d-c1b1-4304-b554-33ede99389d1): UNIVERSITY OF SOUTHAMPTON
- [Provision of Cognos Licences](/contracts/ocds-b5fd17-90b5ef66-0877-46d1-b0a9-841eff154617): UNIVERSITY OF SOUTHAMPTON

## Source

[View the original notice on Contracts Finder](https://www.contractsfinder.service.gov.uk/Notice/c2a3a395-5e64-44bb-9858-49b1acb5cb0f-832522)