Electronic Trial Master File (inc. Electronic Archiving)
Reference ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044 · UNIVERSITY OF SOUTHAMPTON
Closed. Submission deadline: 28 June 2024. Estimated value: £150,000.
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Amounts and figures
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 computerized 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. E-Tendering Portal: The University is utilizing an electronic tendering tool, In-Tend (https://intendhost.co.uk/universityofsouthampton) to manage this procurement and to communicate with potential tenderers. All documentation in relation to this tender can be downloaded from In-Tend. Potential tenderers are advised that there will be no hard copy documents issued and all communications with the University, including the submission of Selection Stage and/or Invitation to Tender resp…
Official publications
| Medium | Reference | Date |
|---|---|---|
| FTS | 018e45ed-5dca-4435-aaee-b74b65e444f0-753261 | 28 May 2024 |
| Contracts Finder | 018e45ed-5dca-4435-aaee-b74b65e444f0-753261 | 28 May 2024 |
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Frequently asked questions
- What is the deadline to bid for this tender?
- The submission deadline is 28 June 2024, 12:00. Check the official source, as dates can be modified.
- What is the estimated value of this tender?
- The estimated value published by the buyer is £150,000.
- Who is the buyer of this tender?
- The contracting authority is UNIVERSITY OF SOUTHAMPTON (United Kingdom).
- How can I bid for public tenders in the United Kingdom?
- Bids are submitted through the official public procurement portal in the United Kingdom. El Vínculo helps you find tenders and analyse their documents; submission always happens at the official source.
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