---
title: "Electronic Trial Master File (inc. Electronic Archiving)"
ocid: "ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044"
markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044.md"
json_url: "https://d3tenders.com/contract/ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044.json"
source: "Contracts Finder"
current_stage: "Award"
buyer: "UNIVERSITY OF SOUTHAMPTON"
published: "2025-03-07"
---

# Electronic Trial Master File (inc. Electronic Archiving)

Buyer: UNIVERSITY OF SOUTHAMPTON  
Current stage: Award  
OCID: ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044

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## Summary

The University of Southampton's Clinical Trials Unit (SCTU) has undergone a public procurement process to acquire an electronic Trial Master File (eTMF), electronic Investigator Site File (eISF), and eArchiving solution meeting regulatory requirements, including Eudralex Vol4 annex 11 for computerised systems. This procurement falls under the industry category of medical information systems with CPV code 48814000. The open procedure below the threshold commenced on the 28th of May 2024, and the tender period concluded on the 28th of June 2024. The anticipated contract period spans from the 7th of March 2025 to the 6th of March 2028, geographically centred in Southampton, England, at SO17 1BJ.

This tender provides numerous opportunities for various businesses, notably those capable of delivering regulatory-compliant electronic document management systems and e-signature solutions. Given the contract’s scale and scope—valued at £135,000—it is apt for small and medium-sized enterprises (SMEs) and voluntary, community, and social enterprises (VCSEs). The awarded contract to Cognidox Limited, an SME based in Cambridge, signifies a substantial growth opportunity for companies specialising in long-term data retrieval and compliance with regulatory standards. By successfully fulfilling this contract, businesses can establish a solid reputation and springboard for further engagements in similar procurement initiatives.

## Notice

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.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Contracts Finder |
| Latest notice | https://www.contractsfinder.service.gov.uk/Notice/c2a3a395-5e64-44bb-9858-49b1acb5cb0f |
| Notice type | Award Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Open |
| Procurement method details | Open procedure (below threshold) |
| Tender suitability | SME, VCSE |
| Awardee scale | SME |
| All stages | Tender, Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 7 Mar 2025 |
| Submission deadline | 28 Jun 2024 |
| Future notice date | Not specified |
| Award date | 7 Mar 2025 |
| Contract period | 7 Mar 2025 - 6 Mar 2028 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £135,000 |
| Lots value | Not specified |
| Awards value | £135,000 |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Not specified |
| Awards status | Active |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | UNIVERSITY OF SOUTHAMPTON |
| Locality | SOUTHAMPTON |
| Post town | Southampton |
| Postcode | SO17 1BJ |
| Country | England |
| ITL 1 | TLJ South East (England) |
| ITL 2 | TLJ3 Hampshire and Isle of Wight |
| ITL 3 | TLJ32 Southampton |
| Local authority | Southampton |
| Electoral ward | Portswood |
| Westminster constituency | Southampton Test |
| Delivery location | Not specified |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | COGNIDOX |

## CPV Codes

### Divisions

- 48 - Software package and information systems

### Codes

- 48814000 - Medical information systems
- 48814100 - Nursing information system
- 48814200 - Patient-administration system
- 48814300 - Theatre management system
- 48814400 - Clinical information system
- 48814500 - Casemix system

## Release History

- 7 Mar 2025 at 15:01 - Award - Award Notice - https://www.contractsfinder.service.gov.uk/Notice/c2a3a395-5e64-44bb-9858-49b1acb5cb0f
- 28 May 2024 at 14:16 - TenderAmendment - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/018e45ed-5dca-4435-aaee-b74b65e444f0
- 28 May 2024 at 10:51 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/018e45ed-5dca-4435-aaee-b74b65e444f0

## Documents

- https://www.contractsfinder.service.gov.uk/Notice/c2a3a395-5e64-44bb-9858-49b1acb5cb0f
  7th March 2025 - Awarded contract notice on Contracts Finder
- https://www.contractsfinder.service.gov.uk/Notice/018e45ed-5dca-4435-aaee-b74b65e444f0
  28th May 2024 - Opportunity notice on Contracts Finder

## Notice URLs

- https://www.southampton.ac.uk/

## Provenance

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