Section one: Contracting authority/entity
one.1) Name and addresses
THE UNIVERSITY OF BIRMINGHAM
Chancellors Close
BIRMINGHAM
B152TT
Contact
Karen Aird
Telephone
+44 1214158491
Country
United Kingdom
NUTS code
UKG31 - Birmingham
Internet address(es)
Main address
https://www.birmingham.ac.uk/index.aspx
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma.
Reference number
SC10895/22
two.1.2) Main CPV code
- 48611000 - Database software package
two.1.3) Type of contract
Supplies
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £587,644.28
two.2) Description
two.2.2) Additional CPV code(s)
- 48610000 - Database systems
- 48620000 - Operating systems
two.2.3) Place of performance
NUTS codes
- UKG - West Midlands (England)
two.2.4) Description of the procurement
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.
two.2.11) Information about options
Options: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Award of a contract without prior publication of a call for competition in the cases listed below
- The procurement falls outside the scope of application of the regulations
Explanation:
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
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No
Section five. Award of contract/concession
Contract No
SC10895/22
Title
GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma.
A contract/lot is awarded: Yes
five.2) Award of contract/concession
five.2.1) Date of conclusion of the contract
30 June 2022
five.2.2) Information about tenders
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor/concessionaire
Medidata Solutions International Limited
London
Country
United Kingdom
NUTS code
- UKI - London
The contractor/concessionaire is an SME
No
five.2.4) Information on value of contract/lot/concession (excluding VAT)
Initial estimated total value of the contract/lot/concession: £587,644.28
Total value of the contract/lot/concession: £587,644.28
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
University of Birmingham
Birmingham
Country
United Kingdom