--- title: "GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma." ocid: "ocds-h6vhtk-034e92" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-034e92" markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-034e92.md" json_url: "https://d3tenders.com/contract/ocds-h6vhtk-034e92.json" source: "Find A Tender Service" current_stage: "Award" buyer: "THE UNIVERSITY OF BIRMINGHAM" published: "2022-07-05" --- # GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma. Buyer: THE UNIVERSITY OF BIRMINGHAM Current stage: Award OCID: ocds-h6vhtk-034e92 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-034e92) [Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-034e92.json) ## Summary The University of Birmingham is seeking to procure a compliant clinical trial database for the GLO-BNHL project, titled "A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma." This procurement falls under the goods category, specifically involving database software packages. The procurement method adopted is limited, with an award procedure conducted without prior publication of a call for competition. The contract was signed on 30th June 2022 and is active with a total value of £587,644.28, requiring the database system to be operational by September 2022. This tender presents a significant opportunity for businesses in the database software and clinical trial management sectors, particularly those with expertise in electronic data capture systems and compliance with regulatory standards. Companies capable of delivering a robust, compliant solutions like Medidata Solutions International Limited, which has a proven track record in supporting clinical trials, will be well-positioned to compete. Businesses that can ensure seamless data transfer and management in accordance with FDA and EMA standards, while also offering strong support for trial amendments, will find this tender particularly relevant for their growth prospects. ## Notice 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. ### Lot Information Lot 1 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. ### Procurement Information 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 ## Key Details | Field | Value | | --- | --- | | Publication source | Find A Tender Service | | Latest notice | https://www.find-tender.service.gov.uk/Notice/018410-2022 | | Notice type | Award Notice | | Procurement type | Standard | | Procurement category | Goods | | Procurement method | Limited | | Procurement method details | Award procedure without prior publication of a call for competition | | Tender suitability | Not specified | | Awardee scale | Large | | All stages | Award | ## Dates | Field | Value | | --- | --- | | Publication date | 5 Jul 2022 | | Submission deadline | Not specified | | Future notice date | Not specified | | Award date | 29 Jun 2022 | | Contract period | Not specified | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | Not specified | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | £587,644 | ## Status | Field | Value | | --- | --- | | Tender status | Complete | | Lots status | Not specified | | Awards status | Active | | Contracts status | Active | ## Buyer | Field | Value | | --- | --- | | Main buyer | THE UNIVERSITY OF BIRMINGHAM | | Locality | BIRMINGHAM | | Post town | Birmingham | | Postcode | B15 2TT | | Country | England | | ITL 1 | TLG West Midlands (England) | | ITL 2 | TLG3 West Midlands | | ITL 3 | TLG31 Birmingham | | Local authority | Birmingham | | Electoral ward | Edgbaston | | Westminster constituency | Birmingham Edgbaston | | Delivery location | TLG West Midlands (England) | ## Supplier | Field | Value | | --- | --- | | Number of suppliers | 1 | | Supplier names | MEDIDATA SOLUTIONS INTERNATIONAL | ## CPV Codes ### Divisions - 48 - Software package and information systems ### Codes - 48610000 - Database systems - 48611000 - Database software package - 48620000 - Operating systems ## Release History - 5 Jul 2022 at 15:47 - Award - Award Notice - https://www.find-tender.service.gov.uk/Notice/018410-2022 ## Notice URLs - https://www.birmingham.ac.uk/index.aspx ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-034e92. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-034e92.json.