Tender Details

Country: United Kingdom
Summary: Electronic Trial Master File (Inc. Electronic Archiving)
GBT Ref No: 101837116
Deadline: 28 Jun 2024
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: GBP 150000
Notice Type: Tender
Document Ref. No.: 2024UoS-1088
Purchaser's Detail:
Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details.
Login to see details
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:

If you are registered member, kindly login to view full details of this tender notice:

Electronic Trial Master File (Inc. Electronic Archiving) - Greatbritain Tender

The UNIVERSITY OF SOUTHAMPTON, a Government sector organization in United Kingdom, has announced a new tender for Electronic Trial Master File (Inc. Electronic Archiving). This tender is published on GreatbritainTenders under GBT Ref No: 101837116 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2024-06-28.

The estimated tender value is GBP 150000, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.