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Electronic Trial Master File (inc. Electronic Archiving)

发布时间 所属地区 所属机构 语言
2024年05月28日 -- -- 英语 (English) 中文

Published date: 28 May 2024

Last edited date: 28 May 2024

Open opportunity - This means that the contract is currently active, and the buying department is looking for potential suppliers to fulfil the contract.

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Closing: 28 June 2024, 12pm

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)

    What is an open procedure (below threshold)?

    Any interested supplier may submit a tender in response to an opportunity notice.

    This procedure can be used for procurements below the relevant contract value threshold.

    Contract is suitable for SMEs?

    Yes

    Contract is suitable for VCSEs?

    Yes


    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.


    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.


    How to apply

    Follow the instructions given in the description or the more information section.


    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/


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