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Tender Details
- Country: United Kingdom
- Summary: Electronic Trial Master File (Inc. Electronic Archiving)
- GBT Ref No: 101837116
- Deadline: 28 Jun 2024
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: 150000
- Notice Type: Tender
- Document Ref. No.: 2024UoS-1088
- Purchaser's Detail :
- Description :
- 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... - Documents :
Purchaser : UNIVERSITY OF SOUTHAMPTON
BUILDING 37, HIGHFIELD CAMPUS,UNIVERSITY ROAD SOUTHAMPTON SO171BJ England
Contact Person : Natasha Rook
Email :procurement@soton.ac.uk
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