Areas of Previous Clinical Trial Work Experience:  We have participated at various steps of biomarker and clinical laboratory test development.  Some of the areas in which we have previously conducted FDA studies for clinical trials are:

• Urine chemistries
• Urine sediments
• Point-of-care platforms
• Cardiac markers
• Therapeutic Drug Monitoring including immunosuppressant
• Drugs of abuse
• Coagulation
• General chemistry
• Pharmacogenetic tests

In addition, we provide immunoassay services for development/optimization of ELISA-based assays and for analysis using ELISA or Luminex-based immunoassays.

Regulatory Concerns:  Our Clinical Trials labs are HIPAA compliant.  We follow good laboratory practices and have policies in place for monitoring freezer and refrigerator temperatures.  Our Institutional Review Board and Human Studies Committees are FDA-Certified and have a rapid turn-around-time for review of new applications.

                                Contact Information:
      Saeed A. Jortani, Ph.D., DABCC, FACB
      Professor of Pathology & Lab Medicine
      Director, Jortani Clinical Trials Laboratories
      Suite 227B,  511 South Floyd Street
      Louisville, Kentucky 40202
      Ph: (502) 852-8835
                               sjortani@louisville.edu

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