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PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome

Electronic data management (EDM)
West Midlands (UKG31)
Published value
Not published
Submission deadline Not published
Lots published1
Procurement Executive Summary
AI & Search Synopsis
Generated from official OCDS record
Tenderline Synopsis: UNIVERSITY OF BIRMINGHAM: "PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome". Published status: complete. Published value: Value not published. 1 published lot. Submission deadline not published. See the official notice for participation instructions.
Contracting AuthorityUNIVERSITY OF BIRMINGHAMScope & CategoriesNot publishedSubmission Window
complete
No deadline published
Submission GatewayDirect notice routeLegal Basis & RegimeStandard procurementEstimated Value (exc. VAT)Not published
Bidder Intelligence · Authority Profile: UNIVERSITY OF BIRMINGHAM
Market Analytics
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Derived from OCDS awards & bid statistics
Published history for UNIVERSITY OF BIRMINGHAM. These figures describe retained records, not a forecast of bids or a measure of buyer bias.
Published-to-award variance
Not availableInsufficient comparable data
Requires at least 5 comparable procedures
Competition Density
1Bids / Report
100% of reports have one bid
Supplier ConcentrationNo estimate
Insufficient attributable awardsNo concentration estimate available
Payment Terms
Check noticePublished terms
Payment obligations depend on the applicable regime and contract. Consult the official documents.
Coverage: 3 active published awards; 1 bid reports (which may be per lot). Supplier values exclude multi-supplier awards, frameworks and DPS, and use GBP only. They are published award values, not payments. Published-to-award variance compares single-lot, single-award, single-supplier GBP procedures with explicitly non-framework/non-DPS status; increases remain in the average. Unpublished data stays unknown. Awarded suppliers are winners, not all bidders.
Procedure terms
Contracting AuthorityUNIVERSITY OF BIRMINGHAM
Procedure methodNot published
Procurement categoryNot published
Statuscomplete
Framework / DPSNot published
CompetitionNot published
Above thresholdNot published
Legal basisNot published
Tender period startsNot published
Clarification deadlineNot published
Electronic submissionNot published
Submission languagesNot published
Published9 Dec 2021, 14:33 GMT
Last source update9 Dec 2021, 14:33 GMT
Recurring procurementNot published
ClassificationElectronic data management (EDM)
Delivery area
West Midlands (UKG31)
OCIDocds-h6vhtk-02ff58
What is being bought
The PARIS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by an industry collaborator. The trial is required to have a suitably compliant clinical trial database (electronic data capture (EDC) system) that is active and ready for use by January 2022. Funding is provided to support the trial to be compliant with additional regulations (International Conference on Harmonization, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards - specifically 21 CFR Part 11 guidance.
What changed
From the official release history
  1. Status changed to complete
    9 Dec 2021, 14:33 GMT
  2. Official notice release published
    9 Dec 2021, 14:33 GMT
  3. Buyer information updated
    9 Dec 2021, 14:33 GMT
Lots and requirements (1)
Published by the contracting authority
  • Lot 1 · #1
    Individual lot title not published
    Status not published
    Published valueNot published
    The PARIS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by an industry collaborator. The trial is required to have a suitably compliant clinical trial database (electronic data capture (EDC) system) that is active and ready for use by January 2022. Funding is provided to support the trial to be compliant with additional regulations (International Conference on Harmonization, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards - specifically 21 CFR Part 11 guidance.
    Contract periodNot published
    EligibilityNot published
    Options / renewalNot published
Timeline
  1. Procedure published
    9 Dec 2021, 14:33 GMT
  2. Award active
    Not published · Not published
  3. Contract active
    Signed 9 Dec 2021, 00:00 GMT · £500,000
Commercial outcome and competition
Awards
Medidata Solutions International Limited
Not published · Not published · active
Contracts
PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome
£500,000 · signed 9 Dec 2021, 00:00 GMT · active
Bid statisticsNo aggregate bid statistics published
Buyer and organisations in this procedure

UNIVERSITY OF BIRMINGHAM

Contracting authority GB-FTS-31013
View buyer profile

  • UNIVERSITY OF BIRMINGHAM
    buyer

    University of Birmingham, BIRMINGHAM, UKG31, B152TT
    s.y.ting@bham.ac.uk

  • Medidata Solutions International Limited
    supplier

    12 Hammersmith Grove, 9th Floor, London, UKI, W6 7AP

  • The University of Birmingham
    reviewBody

    Birmingham, B152TT
Documents (0)
Official links; attachments are not copied
No data
No linked documents are published
Related procedures (0)
No data
No related procedures published
Planning and rationale
Planning budgetNot published
No-engagement rationaleNot published
Procedure rationaleThe preferred vendor for creating an EDC system for this trial is Medidata (Rave). Medidata meets the criteria outlined below that are essential for delivering the clinical trial. The company has a track record of delivering clinical trials to registration standard with other academic organisations and industry partners running clinical trials of this nature and was independently recommended to the University of Birmingham. Additionally, Medidata is in the process of undergoing a detailed audit of their systems with the University of Birmingham. This is an essential requirement to perform prior to the set-up of an electronic clinical trial database when required for registration standard trials. Critically, Medidata have successfully passed inspections by regulatory health authorities. Regular transfers of data to the industry collaborator will be required and therefore we require the same EDC platform to be used for ease of transfer. Medidata have confirmed their ability to deliver the clinical trial database in January 2022, within the budget and using Case Report Form (CRF) libraries held by the industry collaborator. The following are detailed reasons for the selection of Medidata as a vendor to provide an EDC system PARIS: • Experience in relevant disease group (Rheumatoid Arthritis, Ulcerative Colitis, Sjogren's Syndrome) • Access to CRF library for the diseases listed above • Access to industry partner CRF libraries • The same EDC system as the funder (industry collaborator) to enable ease of data transfer • Able to deliver a live clinical trial database for the study by January 2022 • Successfully passed a regulatory inspection and undergoing an audit by the University of Birmingham • Able to demonstrate compliance with regulations across all global regions • Able to implement major trial protocol amendments (new treatment arms) without requiring temporarily closures or existing live aspects of the database • Fall under a maximum budget of £500,000 for the whole clinical trial database