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UNIVERSITY OF SOUTHAMPTON has floated a tender for Electronic Trial Master File (Inc. Electronic Archiving). The project location is United Kingdom and the tender is closing on 28 Jun 2024. The tender notice number is 2024UoS-1088, while the TOT Ref Number is 101837116. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : United Kingdom
Summary : Electronic Trial Master File (Inc. Electronic Archiving)
Deadline : 28 Jun 2024
Other Information
Notice Type : Tender
TOT Ref.No.: 101837116
Document Ref. No. : 2024UoS-1088
Competition : ICB
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : GBP 150000
Purchaser's Detail
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Login to see detailsTender Details
Title : Electronic Trial Master File (inc. Electronic Archiving)
Location Of Contract : SO17 1BJ
Industry : Medical information systems - 48814000 Nursing information system - 48814100 Patient-administration system - 48814200 Theatre management system - 48814300 Clinical information system - 48814400 Casemix system - 48814500
Value Of Contract : £120, 000 to £150, 000
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://in-tendhost.co.uk/universityofsouthampton/aspx/Home) to manage this procurement and to communicate with p...
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