---
title: "PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome"
ocid: "ocds-h6vhtk-02ff58"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-02ff58"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-02ff58.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-02ff58.json"
source: "Find A Tender Service"
current_stage: "Award"
buyer: "UNIVERSITY OF BIRMINGHAM"
published: "2021-12-09"
---

# PARIS Trial Clinical Trials EDC system: A phase 2 study of PD-1 inhibition in Rheumatoid Arthritis, Ulcerative Colitis and Sjogrens syndrome

Buyer: UNIVERSITY OF BIRMINGHAM  
Current stage: Award  
OCID: ocds-h6vhtk-02ff58

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## Summary

The University of Birmingham is seeking a supplier for the PARIS Trial Clinical Trials EDC system, specifically for a phase 2 study involving PD-1 inhibition in conditions such as Rheumatoid Arthritis, Ulcerative Colitis, and Sjögren's syndrome. This procurement falls under the goods category in the electronic data management (EDM) industry, with a contract value of £500,000. The procurement method used is limited, meaning it was negotiated without the publication of a contract notice. The procurement process is currently in the award stage, following the signing of the contract on 9th December 2021, with the system required to be operational by January 2022.

This tender presents significant opportunities for businesses involved in clinical data management and electronic data capture. Companies with experience in trial database systems, particularly those familiar with regulatory compliance across different regions, would be positioned well to compete. Given the specific requirements of the PARIS trial, businesses that can demonstrate expertise in managing clinical trials, suitable technical capabilities, and a clear understanding of the necessary regulations would likely find growth opportunities within this procurement process.

## Notice

The PARIS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by an industry collaborator. 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 January 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 PARIS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by an industry collaborator. 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 January 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

The preferred vendor for creating an EDC system for this trial is Medidata (Rave). Medidata meets the criteria outlined below that are essential for delivering the clinical trial. The company has a track record of delivering clinical trials to registration standard with other academic organisations and industry partners running clinical trials of this nature and was independently recommended to the University of Birmingham. Additionally, Medidata is in the process of undergoing a detailed audit of their systems with the University of Birmingham. This is an essential requirement to perform prior to the set-up of an electronic clinical trial database when required for registration standard trials. Critically, Medidata have successfully passed inspections by regulatory health authorities. Regular transfers of data to the industry collaborator will be required and therefore we require the same EDC platform to be used for ease of transfer. Medidata have confirmed their ability to deliver the clinical trial database in January 2022, within the budget and using Case Report Form (CRF) libraries held by the industry collaborator. The following are detailed reasons for the selection of Medidata as a vendor to provide an EDC system PARIS: * Experience in relevant disease group (Rheumatoid Arthritis, Ulcerative Colitis, Sjogren's Syndrome) * Access to CRF library for the diseases listed above * Access to industry partner CRF libraries * The same EDC system as the funder (industry collaborator) to enable ease of data transfer * Able to deliver a live clinical trial database for the study by January 2022 * Successfully passed a regulatory inspection and undergoing an 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 * Fall under a maximum budget of PS500,000 for the whole clinical trial database

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/030689-2021 |
| Notice type | Award Notice |
| Procurement type | Standard |
| Procurement category | Goods |
| Procurement method | Limited |
| Procurement method details | Negotiated without publication of a contract notice |
| Tender suitability | Not specified |
| Awardee scale | Large |
| All stages | Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 9 Dec 2021 |
| Submission deadline | Not specified |
| Future notice date | Not specified |
| Award date | 9 Dec 2021 |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | £500,000 |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Not specified |
| Awards status | Active |
| Contracts status | Active |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | 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 | TLG31 Birmingham |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | MEDIDATA SOLUTIONS INTERNATIONAL |

## CPV Codes

### Divisions

- 48 - Software package and information systems

### Codes

- 48613000 - Electronic data management (EDM)

## Release History

- 9 Dec 2021 at 14:33 - Award - Award Notice - https://www.find-tender.service.gov.uk/Notice/030689-2021

## Notice URLs

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

## Provenance

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