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Glo-BNHL Central Review of Imaging and Clinical Data

THE UNIVERSITY OF BIRMINGHAM

This public procurement record has 1 release in its history.

Award

21 Jan 2025 at 09:30

Award Notice
Summary of the contracting process

The University of Birmingham has awarded a contract for the central review of imaging and clinical data as part of the Glo-BNHL project—a global study focusing on paediatric and adolescent relapsed and refractory B-cell Non-Hodgkin Lymphoma. This clinical trial is supported by various international childhood cancer research organisations, including the ITCC and EICNHL in Europe, and the COG in North America. The project, funded by Cancer Research UK, Fight Kids Cancer, and industry partners, involves services under the industry category of medical imaging. The contract was signed on 13th December 2024, and it covers work to be performed at locations including the UK, Europe, North America, Australia, New Zealand, and Israel. The contracting process was completed under a negotiated procedure without prior publication, due to unsuccessful tender responses in the open procedure, and is now in the award stage.

This tender presents significant opportunities for businesses, especially those specialising in medical imaging services, global oncology and paediatric trials. Medidata Solutions International Ltd, the selected vendor, brings a wealth of experience and can leverage their existing Glo-BNHL Electronic Data Capture system for seamless integration. Businesses with expertise in conducting independent central reviews, managing large datasets, and adhering to international regulatory requirements would be well-suited for similar contracts. The collaboration underscores the importance of having established relationships, rapid project initiation capabilities, and compliance with global standards, attributes that can drive business growth and extend professional networks in the field of medical and clinical research.

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Notice Information

Notice Title

Glo-BNHL Central Review of Imaging and Clinical Data

Notice Description

Glo-BNHL is an international multi-arm clinical trial developed in collaboration with a number of key childhood cancer research organisations, including Innovative Therapies for Children with Cancer (ITCC) and the European Intergroup for Childhood NHL (EICNHL) in Europe, and the Children's Oncology Group (COG) in North America. The trial will be delivered globally with support from these organisations and in partnership with the C17 Council in Canada and the Australia and New Zealand Children's Haematology and Oncology Group (ANZCHOG). The trial is jointly funded by Cancer Research UK, Fight Kids Cancer and industry collaborators (currently ADC Therapeutics and Regeneron Pharmaceuticals). The funding provided is contingent upon the use of vendors with a track record of delivering clinical trials of this kind. The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham is not able to perform central review of imaging and clinical data, therefore a suitable third-party vendor must be engaged for this critical work.

Lot Information

Lot 1

Glo-BNHL is an international multi-arm clinical trial developed in collaboration with a number of key childhood cancer research organisations, including Innovative Therapies for Children with Cancer (ITCC) and the European Intergroup for Childhood NHL (EICNHL) in Europe, and the Children's Oncology Group (COG) in North America. The trial will be delivered globally with support from these organisations and in partnership with the C17 Council in Canada and the Australia and New Zealand Children's Haematology and Oncology Group (ANZCHOG). The trial is jointly funded by Cancer Research UK, Fight Kids Cancer and industry collaborators (currently ADC Therapeutics and Regeneron Pharmaceuticals). The funding provided is contingent upon the use of vendors with a track record of delivering clinical trials of this kind. The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham is not able to perform central review of imaging and clinical data, therefore a suitable third-party vendor must be engaged for this critical work.

Procurement Information

Glo-BNHL A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma Glo-BNHL is an international multi-arm clinical trial developed in collaboration with a number of key childhood cancer research organisations, including Innovative Therapies for Children with Cancer (ITCC) and the European Intergroup for Childhood NHL (EICNHL) in Europe, and the Children's Oncology Group (COG) in North America. The trial will be delivered globally with support from these organisations and in partnership with the C17 Council in Canada and the Australia and New Zealand Children's Haematology and Oncology Group (ANZCHOG). The trial is jointly funded by Cancer Research UK, Fight Kids Cancer and industry collaborators (currently ADC Therapeutics and Regeneron Pharmaceuticals). The funding provided is contingent upon the use of vendors with a track record of delivering clinical trials of this kind. The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham is not able to perform central review of imaging and clinical data, therefore a suitable third-party vendor must be engaged for this critical work. The preferred vendor for central review of imaging and clinical data is Medidata. Medidata have been selected because: None of the vendors who applied through the open tender process were successful (Medidata did not apply) Medidata already operate the Glo-BNHL Electronic Data Capture (EDC) system which will allow for seamless integration of the central review with the rest of the trial data They have experience in the relevant disease group, B-cell Non-Hodgkin's Lymphoma (B-NHL) They have access to a CRF library for B-NHL and to industry partner CRF libraries They are able to deliver a live global central review system within 6-8 weeks They are able to demonstrate compliance with regulations across all global regions They are able to implement major trial protocol amendments (e.g. new treatment arms) without requiring temporary closures of existing live aspects of the database They can provide visibility on all imaging activity, including access to DICOM files/images, videos, imaging data and metadata They are able to review and mask Patient Health Information (PHI) They offer single sign-on and EDC unification They can provide regulatory compliant digital storage and archival They provide upload check to sites and raise data queries They can allow real-time, read-only access to UoB and can work with any third party imaging specialist to carry out the review They perform data reconciliation between imaging and the EDC When deciding upon a partner to work with us on Glo-BNHL, we felt the expertise detailed above, as well as the following other considerations, made Medidata the right choice for this trial: 1. Experience working with CRCTU o Medidata are familiar with our way of working and the Glo-BNHL study; existing Glo-BNHL EDC protocols and documentation can be quickly adapted, thereby saving time and providing greater value for money o There is no lag time associated with familiarising the Medidata team with the study o Sites will not be required to work with multiple providers and will instead use the Medidata system they are familiar with o We have an established relationship with Medidata and they have already demonstrated their ability to deliver, therefore risk is mitigated by working with them again 2. There is an existing MSA between Medidata and UoB o Having an MSA in place significantly speeds up the process of contracting with Medidata and means we will not delay the progress of the trial, benefiting the patients waiting for novel treatments o We can begin working with Medidata upon execution of a Work Order, significantly reducing the timelines for opening the study as well as reducing the burden on the University support services

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-04d4e5
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/001970-2025
Current Stage
Award
All Stages
Award

Procurement Classification

Notice Type
Award Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Limited
Procurement Method Details
Negotiated without publication of a contract notice
Tender Suitability
Not specified
Awardee Scale
Large

Common Procurement Vocabulary (CPV)

CPV Divisions

85 - Health and social work services

CPV Codes

85150000 - Medical imaging services

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
£685,056 £500K-£1M

Notice Dates

Publication Date
21 Jan 20251 years ago
Submission Deadline
Not specified
Future Notice Date
Not specified
Award Date
13 Dec 20241 years ago
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

Tender Status
Complete
Lots Status
Not Specified
Awards Status
Active
Contracts Status
Active

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
THE UNIVERSITY OF BIRMINGHAM
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
BIRMINGHAM
Postcode
B15 2TT
Postcode Area
Birmingham
Country
England
Major Region (ITL 1)
TLG West Midlands (England)
Basic Region (ITL 2)
TLG3 West Midlands
Small Region (ITL 3)
TLG31 Birmingham
Delivery Location
TLG West Midlands (England)
Local Authority
Birmingham
Electoral Ward
Edgbaston
Westminster Constituency
Birmingham Edgbaston

Supplier Information

Number of Suppliers
1
Supplier Name

Medidata Solutions International Ltd

Further Information

Notice URLs

Open Contracting Data Standard (OCDS)

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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