Clinical Evaluation LLC
Investigator experience
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We have Investigator experience in clinical trials, including Principal Investigator experience in many Phase 1 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.