Electronic Trial Master File (inc. Electronic Archiving)
Details
- Supplier(s)
- Cognidox Limited
- Value
- GBP 135,000
- Duration
- 3 years
- Topic
- Medical information systems
- Published
- 7 March 2025
- Source
- uk:contracts_finder
Tender 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.
Timeline
- Completed: Award published7 March 2025Current notice
- Completed: Award date7 March 2025
- Next: Contract expiry date6 March 2028in 2 years
About the buyer
University of Southampton is a public sector buyer in United Kingdom publishing tenders and awards on Stotles. Explore their procurement activity and find more opportunities like this one.
Relevant CPV codes
- 48814000 · Medical information systems
- 48814100 · Nursing information system
- 48814200 · Patient-administration system
- 48814300 · Theatre management system
- 48814400 · Clinical information system
- 48814500 · Casemix system
Decision makers
Connect with the people behind this procurement.
| Contact name | Job title | Phone number | Work email |
|---|---|---|---|
| Head of Procurement | +44 •••• •••••• | ••••••••@university-of-southampton.gov | |
| Commercial Director | +44 •••• •••••• | ••••••••@university-of-southampton.gov | |
| Procurement Manager | +44 •••• •••••• | ••••••••@university-of-southampton.gov | |
| Category Lead | +44 •••• •••••• | ••••••••@university-of-southampton.gov | |
| Senior Buyer | +44 •••• •••••• | ••••••••@university-of-southampton.gov | |
| Contracts Manager | +44 •••• •••••• | ••••••••@university-of-southampton.gov |
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