Electronic Trial Master File (inc. Electronic Archiving)

Contract summary

Industry

• Medical information systems - 48814000

• Nursing information system - 48814100

• Patient-administration system - 48814200

Show additional CPV codes for this notice

• Theatre management system - 48814300

• Clinical information system - 48814400

• Casemix system - 48814500

Location of contract

SO17 1BJ

Value of contract

£120,000 to £150,000

Procurement reference

2024UoS-1088

Published date

28 May 2024

Closing date

28 June 2024

Closing time

12pm

Contract start date

29 July 2024

Contract end date

28 July 2027

Contract type

Service contract

Procedure type

Open procedure (below threshold)

Contract is suitable for SMEs?

Yes

Contract is suitable for VCSEs?

Yes

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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 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 responses will be conducted via In-Tend.

Regular monitoring of the portal is the responsibility of the potential tenderer. If you are not already registered as a supplier with the University of Southampton, you will need to register in In-Tend in order to access the procurement documentation.

Once you have logged in as a supplier: click on 'Tenders'; locate the relevant project; and click 'View Details'. Once you are in the project screen, you will be able to register your organisation against the project and access all documentation by clicking 'Express Interest'.

Potential suppliers/tenderers are advised that formal expressions of interest in the project must be by way of completion and return of the relevant documents via In-Tend.

Further instructions for the submission of responses are below:
To submit your return:
1. Log in
2. Click 'Tenders'
3. Locate the relevant project
4. View details
5. Click on the tab relating to the relevant project stage (e.g. 'Invitation to Tender')
6. Click on the 'Attach Documents' button and upload your return.
7. Check ALL your response documents are uploaded and displayed in the 'My Tender Return' panel. The system will only permit your organisation to make one return.
8. Click the red 'Submit Return' button.

Please note, to preserve the integrity of the procurement, all communications with the University must be made via the correspondence function within In-Tend.

The University is not liable for any costs in the event of the cancellation of this procurement process.

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More information

Additional text

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 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 responses will be conducted via In-Tend.

Regular monitoring of the portal is the responsibility of the potential tenderer. If you are not already registered as a supplier with the University of Southampton, you will need to register in In-Tend in order to access the procurement documentation.

Once you have logged in as a supplier: click on 'Tenders'; locate the relevant project; and click 'View Details'. Once you are in the project screen, you will be able to register your organisation against the project and access all documentation by clicking 'Express Interest'.

Potential suppliers/tenderers are advised that formal expressions of interest in the project must be by way of completion and return of the relevant documents via In-Tend.

Further instructions for the submission of responses are below:
To submit your return:
1. Log in
2. Click 'Tenders'
3. Locate the relevant project
4. View details
5. Click on the tab relating to the relevant project stage (e.g. 'Invitation to Tender')
6. Click on the 'Attach Documents' button and upload your return.
7. Check ALL your response documents are uploaded and displayed in the 'My Tender Return' panel. The system will only permit your organisation to make one return.
8. Click the red 'Submit Return' button.

Please note, to preserve the integrity of the procurement, all communications with the University must be made via the correspondence function within In-Tend.

The University is not liable for any costs in the event of the cancellation of this procurement process.

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About the buyer

Contact name

Natasha Rook

Address

BUILDING 37, HIGHFIELD CAMPUS,UNIVERSITY ROAD
SOUTHAMPTON
SO171BJ
England

Telephone

023 8059 4586

Email

procurement@soton.ac.uk

Website

https://www.southampton.ac.uk/