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
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.
Contact name: n/a
Address: Bishop Hall Lane
CHELMSFORD
CM11SQ
England
Telephone: 0845 196 4225
Fax: n/a
Email: [email protected]
Price Range: n/a