Glo-BNHL Central Review of Imaging and Clinical Data

Scope, procedure and submissions

Id

SC13334/24

Status

complete

Procurement Method

limited

Main Procurement Category

services

Procurement Method Details

Negotiated without publication of a contract notice

Why this procedure was chosen

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

Lots and requirements

Items and delivery

Buyer, suppliers and contacts

Award information

Contracts and changes

Recorded locations

• Buyer location · BIRMINGHAM · UKG31 · B152TT · United Kingdom
• Delivery location · UKG