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

Concepts

• paris trial
• birmingham
• electronic data management (EDM)
• sjogrens syndrome
• compliant clinical trial database
• paris
• rheumatoid arthritis
• study of pd-1 inhibition
• edc
• trial

Location

Birmingham:

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.

Award Detail

CPV Codes

• 48613000 - Electronic data management (EDM)

Legal 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

Other Information

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