Notice Information
Notice Title
GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma.
Notice 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.
Lot Information
Lot 1
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.
Procurement Information
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
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-h6vhtk-034e92
- Publication Source
- Find A Tender Service
- Latest Notice
- https://www.find-tender.service.gov.uk/Notice/018410-2022
- Current Stage
- Award
- All Stages
- Award
Procurement Classification
- Notice Type
- Award Notice
- Procurement Type
- Standard
- Procurement Category
- Goods
- Procurement Method
- Limited
- Procurement Method Details
- Award procedure without prior publication of a call for competition
- Tender Suitability
- Not specified
- Awardee Scale
- Large
Common Procurement Vocabulary (CPV)
- CPV Divisions
48 - Software package and information systems
-
- CPV Codes
48610000 - Database systems
48611000 - Database software package
48620000 - Operating systems
Notice Value(s)
- Tender Value
- Not specified
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- £587,644 £500K-£1M
Notice Dates
- Publication Date
- 5 Jul 20223 years ago
- Submission Deadline
- Not specified
- Future Notice Date
- Not specified
- Award Date
- 29 Jun 20223 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
- THE UNIVERSITY OF BIRMINGHAM
- Contact Name
- Karen Aird
- Contact Email
- k.aird@bham.ac.uk
- Contact Phone
- +44 1214158491
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
- TLG West Midlands (England)
-
- 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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