Section one: Contracting authority/entity
one.1) Name and addresses
UNIVERSITY OF BIRMINGHAM
University of Birmingham
BIRMINGHAM
B152TT
Contact
Susanna Ting
Country
United Kingdom
NUTS code
UKG31 - Birmingham
Internet address(es)
Main address
https://www.birmingham.ac.uk/index.aspx
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome
Reference number
SC9830/21
two.1.2) Main CPV code
- 48613000 - Electronic data management (EDM)
two.1.3) Type of contract
Supplies
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £500,000
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKG31 - Birmingham
two.2.4) Description of the procurement
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.
two.2.11) Information about options
Options: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Negotiated without a prior call for competition
- The works, supplies or services can be provided only by a particular economic operator for the following reason:
- absence of competition for technical reasons
Explanation:
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 £500,000 for the whole clinical trial database
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section five. Award of contract/concession
Contract No
SC9830/21
Title
PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome
A contract/lot is awarded: Yes
five.2) Award of contract/concession
five.2.1) Date of conclusion of the contract
9 December 2021
five.2.2) Information about tenders
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor/concessionaire
Medidata Solutions International Limited
12 Hammersmith Grove, 9th Floor
London
W6 7AP
Country
United Kingdom
NUTS code
- UKI - London
The contractor/concessionaire is an SME
No
five.2.4) Information on value of contract/lot/concession (excluding VAT)
Total value of the contract/lot/concession: £500,000
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
The University of Birmingham
Birmingham
B152TT
Country
United Kingdom