Published date: 7 March 2025

Awarded contract - This means that the contract has been awarded to a supplier.


Closing: 28 June 2024, 12pm

Contract summary

Industry

  • Medical information systems - 48814000

Location of contract

SO17 1BJ

Value of contract

£90,000 to £135,000

Procurement reference

2024UoS-1088

Published date

7 March 2025

Closing date

28 June 2024

Closing time

12pm

Contract start date

7 March 2025

Contract end date

6 March 2028

Contract type

Service contract

Procedure type

Open procedure (below threshold)

Any interested supplier may submit a tender in response to an opportunity notice.

This procedure can be used for procurements below the relevant contract value threshold.

Contract is suitable for SMEs?

Yes

Contract is suitable for VCSEs?

Yes

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.

More information

Previous notice about this procurement

Electronic Trial Master File (inc. Electronic Archiving)

  • Opportunity
  • Published 28 May 2024, last edited 28 May 2024

Award information

Awarded date

7 March 2025

Contract start date

7 March 2025

Contract end date

6 March 2028

Total value of contract

£135,000

This contract was awarded to 1 supplier.

Cognidox Limited

Address

28 Chesterton Road,
Cambridge,
CB4 3AZ

Reference

Companies House number: 6506232

Value of contract

£135,000

Supplier is SME?

Yes

Supplier is VCSE?

No

About the buyer

Contact name

Hannah Nash

Address

BUILDING 37, HIGHFIELD CAMPUS,UNIVERSITY ROAD
Highfield
SOUTHAMPTON
SO171BJ
England

Telephone

02380595000

Email

procurement@soton.ac.uk

Website

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