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

Database software package
Database systems
Operating systems
West Midlands (UKG)
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 AuthorityTHE UNIVERSITY OF BIRMINGHAMScope & CategoriesNot publishedSubmission Window
complete
No deadline published
Submission GatewayDirect notice routeLegal Basis & RegimeStandard procurementEstimated Value (exc. VAT)Not published
Bidder Intelligence · Authority Profile: THE UNIVERSITY OF BIRMINGHAM
Market Analytics
View Authority Profile →
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.
Published-to-award variance
Not availableInsufficient comparable data
Requires at least 5 comparable procedures
Competition Density
1.6Bids / Report
40% of reports have one bid
Supplier ConcentrationNo estimate
Insufficient attributable awardsNo concentration estimate available
Payment Terms
Check noticePublished terms
Payment obligations depend on the applicable regime and contract. Consult the official documents.
Coverage: 6 active published awards; 5 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. Published-to-award variance 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 Unpublished data stays unknown.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
Published5 Jul 2022, 16:47 BST
Last source update5 Jul 2022, 16:47 BST
Recurring procurementNot published
ClassificationDatabase software package, Database systems, Operating systems
Delivery area
West Midlands (UKG)
OCIDocds-h6vhtk-034e92
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
  1. Status changed to complete
    5 Jul 2022, 16:47 BST
  2. Official notice release published
    5 Jul 2022, 16:47 BST
  3. Buyer information updated
    5 Jul 2022, 16:47 BST
Lots and requirements (1)
Published by the contracting authority
  • Lot 1 · #1
    Individual lot title not published
    Status not published
    Published valueNot published
    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.
    Contract periodNot published
    EligibilityNot published
    Options / renewalNot published
Timeline
  1. Procedure published
    5 Jul 2022, 16:47 BST
  2. Award active
    Not published · Not published
  3. Contract active
    Signed 30 Jun 2022, 00:00 BST · £587,644
Commercial outcome and competition
Awards
Medidata Solutions International Limited
Not published · Not published · active
Contracts
GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma.
£587,644 · signed 30 Jun 2022, 00:00 BST · active
Bid statisticsNo aggregate bid statistics published
Buyer and organisations in this procedure

THE UNIVERSITY OF BIRMINGHAM

Contracting authority GB-FTS-57526
View buyer profile

  • THE UNIVERSITY OF BIRMINGHAM
    buyer

    Chancellors Close, BIRMINGHAM, UKG31, B152TT
    k.aird@bham.ac.uk
    +44 1214158491

  • Medidata Solutions International Limited
    supplier

    London, UKI

  • University of Birmingham
    reviewBody

    Birmingham
Documents (0)
Official links; attachments are not copied
No data
No linked documents are published
Related procedures (0)
No data
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