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Electronic Trial Master File (inc. Electronic Archiving)

UNIVERSITY OF SOUTHAMPTON

Buyer Contact Info

Buyer Name: UNIVERSITY OF SOUTHAMPTON

Buyer Address: BUILDING 37, HIGHFIELD CAMPUS,UNIVERSITY ROAD, Highfield, SOUTHAMPTON, SO171BJ, England

Contact Name: Hannah Nash

Contact Email: procurement@soton.ac.uk

Contact Telephone: 02380595000

Status
complete
Procedure
open
Value
135000.0 GBP
Published
07 Mar 2025, 15:01
Deadline
28 Jun 2024, 11:00
Contract Start
07 Mar 2025, 00:00
Contract End
06 Mar 2028, 23:59
Category
services
CPV
48814000 - Medical information systems
Region
n/a
Awarded To
Cognidox Limited
Official Source
Open Contracts Finder

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.

Linked Documents

No linked documents found for this notice.

Opportunity Context

Raw Notice JSON

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