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Official procurement procedure
GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma.
Database and operating software package
Published value
Not published
Submission deadline Not published
Lots published1
Procurement Executive Summary
AI & Search Synopsis
Generated from official OCDS record
Tenderline Synopsis: THE UNIVERSITY OF BIRMINGHAM: "GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma.". Published status: complete. Published value: Value not published. 1 published lot. Submission deadline not published. See the official notice for participation instructions.
| Contracting Authority | THE UNIVERSITY OF BIRMINGHAM | Scope & Categories | Not published | Submission Window | complete No deadline published |
|---|---|---|---|---|---|
| Submission Gateway | Direct notice route | Legal Basis & Regime | Standard procurement | Estimated Value (exc. VAT) | Not published |
Bidder Intelligence · Authority Profile: THE UNIVERSITY OF BIRMINGHAM
Market Analytics
Derived from OCDS awards & bid statistics
Published history for THE UNIVERSITY OF BIRMINGHAM. These figures describe retained records, not a forecast of bids or a measure of buyer bias.
Average Price Reduction
Not availableInsufficient comparable data
Competition Density
3.4Bids / Report
Supplier ConcentrationNo estimate
Insufficient attributable awardsNo concentration estimate availablePayment Terms
Check noticePublished terms
Coverage: 152 active published awards; 31 bid reports (which may be per lot). Supplier values exclude multi-supplier awards, frameworks and DPS, and use GBP only. They are published award values, not payments. Price reduction compares single-lot, single-award, single-supplier GBP procedures with explicitly non-framework/non-DPS status; increases remain in the average. Unpublished data stays unknown. Awarded suppliers are winners, not all bidders.
Procedure terms
Contracting AuthorityTHE UNIVERSITY OF BIRMINGHAM | Procedure methodNot published | Procurement categoryNot published |
Statuscomplete | Framework / DPSNot published | CompetitionNot published |
Above thresholdNot published | Legal basisNot published | Tender period startsNot published |
Clarification deadlineNot published | Electronic submissionNot published | Submission languagesNot published |
Published30 Jun 2023, 13:21 BST | Last source update30 Jun 2023, 13:21 BST | Recurring procurementNot published |
ClassificationDatabase and operating software package | ||
Delivery area | ||
OCIDocds-h6vhtk-03dddf | ||
What is being bought
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.
What changed
From the official release history
- Status changed to complete
30 Jun 2023, 13:21 BST - Official notice release published
30 Jun 2023, 13:21 BST - Buyer information updated
30 Jun 2023, 13:21 BST
Lots and requirements (1)
Published by the contracting authority
- Lot 1 · #1Individual lot title not publishedStatus not publishedPublished valueNot publishedThe 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.Contract periodNot publishedEligibilityNot publishedOptions / renewalNot published
Timeline
- Procedure published
30 Jun 2023, 13:21 BST - Award active
Not published · Not published - Contract active
Signed 30 Jun 2023, 00:00 BST · £324,844
Commercial outcome and competition
Awards Medidata Solutions International Ltd Not published · Not published · active |
Contracts Contract £324,844 · signed 30 Jun 2023, 00:00 BST · active |
Bid statisticsNo aggregate bid statistics published |
Buyer and organisations in this procedure
THE UNIVERSITY OF BIRMINGHAM
Contracting authority GB-COH-RC000645Documents (0)
Official links; attachments are not copied
No linked documents are published
Related procedures (0)
No related procedures published
Planning and rationale
Planning budgetNot published |
No-engagement rationaleNot published |
Procedure rationaleMedidata 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 |