Find a TenderAwarded without competition

Published 5 Jul 2022, 16:47 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£587,644published contract · exc. VAT

Awarded 30 Jun 2022no 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 software package · Database systems · Operating systems

The lotProcurement structure

single lot · no lot value published

Lot #1

Delivery: West Midlands

48610000 Database systems 48620000 Operating systems

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: 5 Jul 2022, 16:47 BST
Last source update: 5 Jul 2022, 16:47 BST
Authority reference: SC10895/22
FTS notice number: 2022/S 000-018410
Classification (CPV): Database software packageDatabase systemsOperating systems
Delivery area: West Midlands (UKG)
Official registry OCID: ocds-h6vhtk-034e92 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 £587,6441 contract exc. VAT

Contracts signed 1latest 30 Jun 2022

Awarded to	Value	Date	Status
Medidata Solutions International Limited	£587,644 †	—	Awarded

Contracts

GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma. · Medidata Solutions International Limited
Signed
30 Jun 2022
Value
£587,644
Status
active

Contracting authority & participating public bodies

THE UNIVERSITY OF BIRMINGHAM

Contracting authorityEducationBody governed by public lawEducation Chancellors Close, BIRMINGHAM, West Midlands, B152TTContact name, email, phone

Dispute resolution & review bodies

University of BirminghamReview body Birmingham

Bidders & participating suppliers

1 commercial party on the notice

Medidata Solutions International LimitedAwarded supplier London, London

Official documents & specifications

Official links; attachments are not copied

No document links were published on the notice.