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Published 30 Jun 2023, 13:21 BST

Official UK procurement notice

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

Official notice

Authority: THE UNIVERSITY OF BIRMINGHAM (Education)

GoodsAward procedure without prior publication of a call for competition
Sectors: Software Packages & ERP (48) Delivery: West Midlands (UKG)
Awarded value£324,844published contract · exc. VAT
Awarded 30 Jun 2023no call for competition
Awarded to Medidata Solutions International Limited

What is being bought

Published requirement 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.

CPV: Database and operating software package

The lotProcurement structure

single lot · no lot value published
Lot #1
Delivery: West Midlands
48600000 Database and operating software package

Procedure terms & legal framework

From the official record
Procedure method
Award procedure without prior publication of a call for competition
Legal basis
CELEX · 32014L0024 Public Contracts Regulations 2015 (Directive 2014/24/EU)
Procurement category
Goods
Notice status
Awarded without competition
Procurement threshold
Unspecified in notice
Regulatory regime
Standard
Commercial structure
Stand-alone contract (no framework)
Competition type
Direct award (no call for competition)
GPA / WTO covered
Unspecified in notice
Recurring procurement
Unspecified in notice
First published
30 Jun 2023, 13:21 BST
Last source update
30 Jun 2023, 13:21 BST
Authority reference
SC10895/22
FTS notice number
2023/S 000-018679
Classification (CPV)
Database and operating software package
Delivery area
West Midlands (UKG)
Official registry OCID
ocds-h6vhtk-03dddf Find a Tender
Why no open competition
The procurement falls outside the scope of application of the directive
Published 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

Commercial outcome & contract awards

Published awards, contracts and bid statistics, not a forecast
Awards 1
Awarded value £324,8441 contract exc. VAT
Contracts signed 1latest 30 Jun 2023
Awarded toValueDateStatus
Medidata Solutions International Limited£324,844 †—Awarded

Contracts

Contracting authority & participating public bodies

THE UNIVERSITY OF BIRMINGHAM

Contracting authorityEducationBody governed by public lawEducation GB-COH: RC000645 EDGBASTON, BIRMINGHAM, West Midlands, B152TTContact name, email, phone

Dispute resolution & review bodies

Bidders & participating suppliers

1 commercial party on the notice

Official documents & specifications

Official links; attachments are not copied

No document links were published on the notice.