Contract Summary

  • Published Date: 22 March 2021

  • Tender Status: complete

  • Tender Opening Date: n/a

  • Tender Closing Date: 21 January 2021

  • Award Date: 16 February 2021

  • Contract Start Date: 28 February 2021

  • Contract End Date: 27 February 2022

  • Contract is suitable for SMEs: Yes

  • Contract is suitable for VCSEs: No

  • Official Journal of the European Union (OJEU) Contract Type: Services

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Description

This has been awarded.

The Clinical Trials Unit (CTU) needs an electronic data capture (EDC) system for its research projects. The features of this system need to have a data entry module, study design module, data management (query resolution) aspect, management of system and users, reportable, and fully auditable.

This system needs to be compliant with ICH GCP, EU Clinical Trial Directive and MHRA regulations to demonstrate that they conform with internationally recognised ethical and scientific quality requirements for the design, conduct, recording and reporting of clinical trials.

FDA 21 CFR Part 11 compliance is also recommended to meet US standards.

About the Buyer

Contact name: n/a

Address: Bishop Hall Lane
CHELMSFORD
CM11SQ
England

Telephone: 0845 196 4225

Fax: n/a

Email: [email protected]

Value of Contract

Price Range: n/a