Notice Information
Notice Title
PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome
Notice Description
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.
Lot Information
Lot 1
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.
Procurement Information
The 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 PS500,000 for the whole clinical trial database
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-h6vhtk-02ff58
- Publication Source
- Find A Tender Service
- Latest Notice
- https://www.find-tender.service.gov.uk/Notice/030689-2021
- Current Stage
- Award
- All Stages
- Award
Procurement Classification
- Notice Type
- Award Notice
- Procurement Type
- Standard
- Procurement Category
- Goods
- Procurement Method
- Limited
- Procurement Method Details
- Negotiated without publication of a contract notice
- Tender Suitability
- Not specified
- Awardee Scale
- Large
Common Procurement Vocabulary (CPV)
- CPV Divisions
48 - Software package and information systems
-
- CPV Codes
48613000 - Electronic data management (EDM)
Notice Value(s)
- Tender Value
- Not specified
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- £500,000 £500K-£1M
Notice Dates
- Publication Date
- 9 Dec 20214 years ago
- Submission Deadline
- Not specified
- Future Notice Date
- Not specified
- Award Date
- 9 Dec 20214 years ago
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Not Specified
- Awards Status
- Active
- Contracts Status
- Active
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- UNIVERSITY OF BIRMINGHAM
- Contact Name
- Susanna Ting
- Contact Email
- s.y.ting@bham.ac.uk
- Contact Phone
- Not specified
Buyer Location
- Locality
- BIRMINGHAM
- Postcode
- B15 2TT
- Post Town
- Birmingham
- Country
- England
-
- Major Region (ITL 1)
- TLG West Midlands (England)
- Basic Region (ITL 2)
- TLG3 West Midlands
- Small Region (ITL 3)
- TLG31 Birmingham
- Delivery Location
- TLG31 Birmingham
-
- Local Authority
- Birmingham
- Electoral Ward
- Edgbaston
- Westminster Constituency
- Birmingham Edgbaston
Further Information
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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