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

Official notice

Authority: THE UNIVERSITY OF BIRMINGHAM (Education)

GoodsNegotiated without publication of a contract notice

Sectors: Software Packages & ERP (48) Delivery: West Midlands (UKG31)

Awarded value£500,000published contract · exc. VAT

Awarded 9 Dec 2021

Awarded to Medidata Solutions International Limited

What is being bought

Published requirement 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.

CPV: Electronic data management (EDM)

The lotProcurement structure

single lot · no lot value published

Lot #1

Delivery: West Midlands

Procedure terms & legal framework

From the official record

Procedure method: Negotiated without publication of a contract notice
Legal basis: CELEX · 32014L0024 Public Contracts Regulations 2015 (Directive 2014/24/EU)
Procurement category: Goods
Notice status: Awarded
Procurement threshold: Unspecified in notice
Regulatory regime: Standard
Commercial structure: Stand-alone contract (no framework)
Competition type: Competitive procedure
GPA / WTO covered: Yes (GPA)
Recurring procurement: Unspecified in notice
First published: 9 Dec 2021, 14:33 GMT
Last source update: 9 Dec 2021, 14:33 GMT
Authority reference: SC9830/21
FTS notice number: 2021/S 000-030689
Classification (CPV): Electronic data management (EDM)
Delivery area: West Midlands (UKG31)
Official registry OCID: ocds-h6vhtk-02ff58 Find a Tender

Why no open competition

The works, supplies or services can be provided only by a particular economic operator due to absence of competition for technical reasons

Published justification

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

Commercial outcome & contract awards

Published awards, contracts and bid statistics, not a forecast

Awards 1

Awarded value £500,0001 contract exc. VAT

Contracts signed 1latest 9 Dec 2021

Awarded to	Value	Date	Status
Medidata Solutions International Limited	£500,000 †	—	Awarded

Contracts

PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome · Medidata Solutions International Limited
Signed
9 Dec 2021
Value
£500,000
Status
active

Contracting authority & participating public bodies

UNIVERSITY OF BIRMINGHAM

Contracting authorityEducationBody governed by public lawEducation University of Birmingham, BIRMINGHAM, West Midlands, B152TTContact name, email

Dispute resolution & review bodies

The University of BirminghamReview body Birmingham

Bidders & participating suppliers

1 commercial party on the notice

Medidata Solutions International LimitedAwarded supplier 12 Hammersmith Grove, 9th Floor, London, London, W6 7AP

Official documents & specifications

Official links; attachments are not copied

No document links were published on the notice.