Notice Information
Notice Title
Electronic Trial Master File (inc. Electronic Archiving)
Notice 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.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044
- Publication Source
- Contracts Finder
- Latest Notice
- https://www.contractsfinder.service.gov.uk/Notice/c2a3a395-5e64-44bb-9858-49b1acb5cb0f
- Current Stage
- Award
- All Stages
- Tender, Award
Procurement Classification
- Notice Type
- Award Notice
- Procurement Type
- Standard
- Procurement Category
- Services
- Procurement Method
- Open
- Procurement Method Details
- Open procedure (below threshold)
- Tender Suitability
- SME, VCSE
- Awardee Scale
- SME
Common Procurement Vocabulary (CPV)
- CPV Divisions
48 - Software package and information systems
-
- CPV Codes
48814000 - Medical information systems
48814100 - Nursing information system
48814200 - Patient-administration system
48814300 - Theatre management system
48814400 - Clinical information system
48814500 - Casemix system
Notice Value(s)
- Tender Value
- £135,000 £100K-£500K
- Lots Value
- Not specified
- Awards Value
- £135,000 £100K-£500K
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 7 Mar 202511 months ago
- Submission Deadline
- 28 Jun 2024Expired
- Future Notice Date
- Not specified
- Award Date
- 7 Mar 202511 months ago
- Contract Period
- 7 Mar 2025 - 6 Mar 2028 3-4 years
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Not Specified
- Awards Status
- Active
- Contracts Status
- Not Specified
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- UNIVERSITY OF SOUTHAMPTON
- Contact Name
- Hannah Nash
- Contact Email
- procurement@soton.ac.uk
- Contact Phone
- 02380595000
Buyer Location
- Locality
- SOUTHAMPTON
- Postcode
- SO17 1BJ
- Post Town
- Southampton
- Country
- England
-
- Major Region (ITL 1)
- TLJ South East (England)
- Basic Region (ITL 2)
- TLJ3 Hampshire and Isle of Wight
- Small Region (ITL 3)
- TLJ32 Southampton
- Delivery Location
- Not specified
-
- Local Authority
- Southampton
- Electoral Ward
- Portswood
- Westminster Constituency
- Southampton Test
Further Information
Notice Documents
-
https://www.contractsfinder.service.gov.uk/Notice/c2a3a395-5e64-44bb-9858-49b1acb5cb0f
7th March 2025 - Awarded contract notice on Contracts Finder -
https://www.contractsfinder.service.gov.uk/Notice/018e45ed-5dca-4435-aaee-b74b65e444f0
28th May 2024 - Opportunity notice on Contracts Finder
Notice URLs
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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