Electronic Trial Master File
Details
- Published
- 1 June 2024
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. <br /><br />The SCTU expects 4-6 new trials a year, and 25 trials recruiting at any one time.<br />
Timeline
- Completed: Tender published1 June 2024Current notice
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.
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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