This Unit deals with the development of computational systems that manage the operations, processes, and data involved in clinical trials. These electronic systems enable the centralized, standardized and controlled collection of all trial data, and support researchers in the proper performance of the trial activities provided by the protocol.
Activities
• Development and maintenance of innovative electronic systems for clinical research that comply with the criteria provided in Part 11 of the CFR21.
• Development and maintenance of the Web interactive System for e-CRF (WISE) according to the proposed clinical protocols.
• Management of the electronic systems user roles and access.
• Cooperation with the Pharmacovigilance and Monitoring Office and statisticians for research data checks and extraction.
