About Us
Patricia Kasper, MS
Owner, P. Kasper & Associates
Patty Kasper is a recognized expert in clinical research training and operations. Since founding P. Kasper & Associates in 1995, she and her senior clinical research consulting team have brought well-designed training programs to the biopharmaceutical and medical device industries. Her hallmark hands-on interactive learning modules bring an exciting real-world element to her classes increasing the effectiveness of the training environment.
Patty has direct experience with Phase 1 through 4 clinical research trials in numerous indications and has directed studies in the US, Canada and Europe. Over the last 15 years, she and her team have successfully guided numerous biopharmaceutical companies through the rigors of drug development.
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Patricia Kasper, MS |
With a passion for sharing her experience and knowledge, Patty's personal and professional philosophy is Learn to Grow. A quest for knowledge is what moves us forward in our life, as well as our career, and creates a recognition of the necessity to continually expand our horizons.
Patty earned a MS in Bacteriology and Public Health from Washington State University. She has been on the faculty of UC Santa Cruz Extension since 1999 as part of their prestigious Clinical Trials Design and Management Certificate Program.
Tricia Cheney, BS
Owner, Training and Clinical Research Consulting
Tricia Cheney owns a consulting business providing specialized training and clinical operations expertise to the
biopharmaceutical and medical device industries. She has designed and developed numerous highly interactive training workshops
that provide participants with a better understanding of the clinical research process and its relationship to regulatory approvals.
Ms. Cheney has extensive experience directing Phase 1 through 3 clinical research trials in a wide variety of therapeutic areas
in the US, Canada, and Europe. She has been responsible for four products that have received regulatory approval for marketing.
Tricia has also written and trained on standard operation procedures (SOPs) for many biopharmaceutical and device companies.
She is on the faculty of the University of California Santa Cruz Extension where she has taught one of the elective courses
in monitoring for the Clinical Trials Design and Management Certificate Program since it began in 1999.
Tricia received her BS from Madison College in Biology/Chemistry, completed her Medical Technology internship at the University
of Virginia, and has completed 29 units towards her MS in Clinical Sciences from San Francisco State University.
Karin Kerber-Smith, BS
Independent Regulatory Consultant
Karin Kerber-Smith has been an independent regulatory consultant since 2002. She was formerly Director, Regulatory Affairs
at Pacific Research Associates/ICON Clinical Research.
Ms. Kerber-Smith has extensive drug development experience in the pharmaceutical industry, encompassing preclinical and
clinical research, development and execution of regulatory strategies, and preparation and management of regulatory filings.
Ms. Kerber-Smith received her BS from the University of California, Davis.
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