GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma

Concepts

• cell non-hodgkin lymphoma
• glo-bnhl trial
• birmingham
• database and operating
• glo-bnhl
• global study of novel agents
• platform study
• adolescent relapsed
• refractory b-cell non-hodgkin lymphoma
• paediatric

Location

West Midlands England:

Description

The GLO-BNHL trial (sponsored by the University of Birmingham) is a platform study which is funded by industry collaborators and Cancer Research UK. 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 September 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

• 48600000 - Database and operating software package

Legal Justification

Medidata Rave are an established provider of electronic remote data capture (eRDC) systems. The company has a track record of delivering clinical trial databases to 21 CFR Part 11 standards. Additionally, Medidata has undergone a detailed audit of their systems by the University of Birmingham and have successfully passed inspections by regulatory health authorities. The industry collaborator use Medidata Rave as their database provider and as such house a Case Report Form (CRF) Library within the platform which will be used for this trial. This library is not accessible elsewhere. In addition, regular transfers of data to the industry collaborator will be required which require the same eRDC system for ease of transfer. Additionally, drug supply will be managed within the system and Medidata have established relationships with the industry partners preferred drug distributor. The following are detailed reasons for the selection of Medidata as a vendor to provide an EDC system GLO-BNHL: • Experience in relevant disease group • Access to CRF library for the disease area • Access to industry partner CRF libraries • The same eRDC system as the funder (industry collaborator) to enable ease of data transfer • Able to deliver a live clinical trial database for the study by September 2022 • Successfully passed a regulatory inspection and 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. • Able to manage a treatment management system with direct access to drug distributor systems

Other Information

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