CTU Electronic Data Capture

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.