Clinical Trial Site (Hospital) Development & Management
We, at Consortium Clinical Research give utmost importance to our Site Management Operations (SMO) because the most important and critical part of Clinical Trial Projects are carried out in hospitals.
From our inception, we have been continuously investing our resources in developing and managing reputed hospitals as Clinical Research Sites across India.
Our Site Management services include preparing necessary Standard Operating Procedures (SOP’s), Constitution, Registration and Management of Institutional Ethics Committee/Institutional Review Board, Training and Certification of Ethics Committee Members and Hospital Staff, Deployment of Trained Clinical Research Coordinators and Site Management support, managing the monitoring and audit visits from both the sponsor as well as the FDA. We also add value by verifying the agreements, pursuing negotiations and coordinating necessary follow up for payments.
We also carry out immense responsibilities of the sponsors, work with the chosen investigators, and ensure that the integrity and credibility of the data collected have a high percentage of adherence to the protocol, the documented SOPs, and to the statutory requirements.