Clinical Evaluation LLC
Investigator experience
-
We have Investigator experience in clinical trials, including Principal Investigator experience in many trials, comprising studies of monoclonal antibodies, aptamers, nerve agent protectants, neuroreceptor compounds, novel anticoagulants, cardioactive, and antiviral drugs. Our Director has acted as Reviewer for Department of Veterans Affairs Phase 2 and 3 study proposals, has consulted on the design of Phase 3 protocols for biologics, and has published results of Preclinical and Phase 1 and 2 trials.
We have fulfilled the following responsibilities for clinical studies in the Investigational New Drug (IND) environment:
- review and evaluation of the medical, scientific and technical aspects of study proposals and protocols;
- acting as central focus of interaction with the Institutional Review Board;
- review of specific study protocol elements with the sponsor/client;
- ensuring that selection criteria for patients or normal subjects are appropriate;
- making decisions on patient and volunteer subject inclusion or exclusion in clinical trials;
- provision of medical oversight and scientific direction of clinical trials;
- supervision of physician, nurse practitioner, nurse, technician and Study Coordinator activities in the conduct of human trials;
- evaluation of adverse events and assignment of causality.