Research Center Phase I Studies

Phase I Studies

The CTI CRC Phase I unit is a state-of-the-art facility designed specifically to conduct early phase clinical pharmacology trials.  Located on the campus of Mercy Hospital, this unit has access to a variety of clinical support services and emergency facilities.  Additionally, the Phase I unit is just minutes from downtown Cincinnati, Ohio and its surrounding suburbs, thus providing convenient access to a large metropolitan population. 

CTI is well versed with the intricacies and challenges associated with Phase I studies and has successfully completed phase I trials involving healthy volunteers and various patient populations.  Our years of experience in the conduct of clinical trials and in the execution of early phase studies has positioned CTI as one of the premier clinical research sites in the United States.  

Gail Kushner, RN, BSN, CCRC
Clinical Site Director
Gail's background in nursing and patient care, along with nearly two decades of experience in research site management, are invaluable asset to both our organization and to our sponsors.

Kushner

We attend industry meetings and are members of many pharmacology societies, including the American College of Clinical Pharmacology (ACCP) and the American Society for Clinical Pharmacology and Therapeutics (ASCPT).

Phase I Unit Experience

  • First-in-human
  • SAD / MAD
  • PK / PD
  • Monoclonal antibodies / Biologics
  • Proof-of-concept
  • Bioavailability / Bioequivalence
  • Crossover designs
  • Food effect
  • Drug-interaction
  • CYP2D6 metabolizers
  • Vaccine
  • Adaptive design

Phase I Unit Capabilities

  • 60 bed capacity
  • Emergency room services
  • On-site clinical laboratory
  • On-site investigational pharmacy
  • On-site hospital imaging (X-Ray, MRI, CT, Dexa, etc.)
  • Holter-Monitoring
  • Neuro-cognitive testing
  • EEG / Polysommnography
  • Full body plethysmograph
  • -70ºC and -20ºC freezers with emergency back-up
  • Multiple recreation areas for subjects
  • Automated / Bar-coded sample management

 

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