Medical Investigators
All safety studies, and most claims substantiation studies, require test panelists to undergo medical examinations. Accordingly, RCTS maintains consulting relationships with board-certified physicians in dermatology, ophthalmology, gynecology, pediatrics, and colorectal surgery.
Examinations are performed by physicians at the initiation and conclusion of a study. Additional physician examinations can be included upon request. Final reports are reviewed and signed by the medical investigator.
Our consulting physicians include:
Raymond Garcia, M.D., Board Certified Dermatologist
Max Adler, M.D., Board Certified Dermatologist and Board Certified Pediatrician
Ponciano Cruz, M.D., Board Certified Dermatologist
Michael S. Harris, M.D., Board Certified Ophthalmologist
James T. Boyd, M.D., Board Certified Gynecologist
Irwin J. Kerber, M.D., Board Certified Gynecologist
Barry Bergman, M.D., Board Certified Pediatrician
Robert Jacobson, M.D., Board Certified Colo-Rectal Surgeon
Biostatistician
RCTS also maintains a consulting relationship with Bruce C. Stouch, Ph.D., a professional biostatistician with more than two decades of clinical biostatistics experience. Dr. Stouch provides expert statistical analysis of study data and, when needed, is available for pre-study advice on protocol design.
Institutional Review Board (IRB)
RCTS has relationships with several external IRBs, the members of which are all selected in accordance with FDA guidelines. RCTS is very familiar with the IRB submission process and will handle submission of all IRB documentation.
IRB review is required for all pharmaceutical trials, device trials, and for any trial the data of which is intended for submission to the FDA. In addition, IRB review is required for all clinical trials involving a vulnerable population, for example, pediatric trials.