Types of Studies

• First Time in Man
• Special Population/Methodology
• Drug Interaction
• Bioavailability / Bioequivalence Trials
• Proof of Target / Biomarker validity
• ADME

Experience with a broad range of clinical study types and designs including:

• FTIM
• Pharmacogenomics
• QTc Safety Monitoring
• Psychological Components
• Select Patient Populations
• Concentration-controlled Trials
• Radiolabel studies (NRC Licensed)

Audits

• FDA
  • No major items found. FDA auditors have complimented our unit on the completeness and thoroughness of our records
• Compliance
  • Served as training of new individuals to the Compliance area
  • Served as design and training site for new clinic