Electronic Trial Master File (inc. Electronic Archiving)
Details
- Value
- £112,500
- Topic
- Medical information systems
- Published
- 28 May 2024
- Submission
- 28 June 2024
- 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: Tender published28 May 2024Current notice
- Completed: Submission date28 June 2024
About the buyer
University of Southampton is a higher education institution whose procurement team runs tenders and quotations under its own financial regulations. Many contracts are awarded through framework agreements managed by the Southern Universities Procurement Consortium. Purchasing teams raise orders and requisitions for faculties and professional service groups. Procurement thresholds set the route to market, ranging from a single quotation to a formal tender.
Over the past 5 years, most of University of Southampton's contract awards have been in software and information systems, office and computing equipment and architectural and engineering services.
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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