---
title: "GLO-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell non-Hodgkin Lymphoma."
ocid: "ocds-h6vhtk-03dddf"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03dddf"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-03dddf.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-03dddf.json"
source: "Find A Tender Service"
current_stage: "Award"
buyer: "THE UNIVERSITY OF BIRMINGHAM"
published: "2023-06-30"
---

# 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-03dddf

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## Summary

The University of Birmingham has awarded a contract for the GLO-BNHL study to Medidata Solutions International Limited. The study involves a global investigation of novel agents in paediatric and adolescent relapsed and refractory B-cell non-Hodgkin lymphoma. The procurement method was a limited award procedure without prior publication. The deadline for deploying a compliant clinical trial database is September 2022. The contract value is £324,844 GBP.

This tender provides an opportunity for businesses experienced in providing electronic data capture systems for clinical trials, specifically meeting 21 CFR Part 11 standards. Companies with expertise in managing clinical trial databases with a focus on regulatory compliance and drug supply management are well-suited to compete. The University of Birmingham, as the buying organization, seeks suppliers capable of delivering live clinical trial databases by specific deadlines and demonstrating compliance with global regulations.

## 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/018679-2023 |
| 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 | 30 Jun 2023 |
| Submission deadline | Not specified |
| Future notice date | Not specified |
| Award date | 29 Jun 2023 |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | £324,844 |

## 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 LIMITED LONDON |

## CPV Codes

### Divisions

- 48 - Software package and information systems

### Codes

- 48600000 - Database and operating software package

## Release History

- 30 Jun 2023 at 12:21 - Award - Award Notice - https://www.find-tender.service.gov.uk/Notice/018679-2023

## Notice URLs

- https://www.birmingham.ac.uk/

## Provenance

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