Specialized Studies / Therapeutics

Specialized Studies/Therapeutics

CEDRA conducts very specialized studies requiring state-of-the-art techniques, staffing, equipment and facilities. Among these Specialized Studies are:

  • Maximum Tolerated Dose (MTD) (Bridging) studies define the tolerable dose range early in the development process, allowing confidence in knowing the common AE profile and highest tolerable dose that can be used in Phase II.
  • Cerebrospinal Fluid (CSF) Dynabridging studies employ discreet and continuous time point collections to confirm brain penetration of psychotropic agents, their PK profile in the brain, and action on neurotransmitters and/or other strategy biomarkers.
  • Rescue and complex studies that have faltered on enrollment or procedural expertise.
  • Specialized later phase studies that require inpatient monitoring.
  • Thorough QTc studies are conducted with state-of-the-art Mortara telemetry equipment and capability for data reading and transmission to your specifications.

CEDRA has developed and conducted these studies and can assist you in designing and conducting your own specialized trials in our new Specialized Studies Unit in San Antonio. Our staff, headed by CEDRA Medical Director, Mark Leibowitz M.D., is comprised of experienced, board-certified physicians, nurses, psychologists, psychometricians, pharmacists, pharmacokineticists, paramedics and other dedicated staff who can provide the 24-hour coverage these studies demand.