PROFILE


Pascal Leemann-Pluot, is the President and Senior Consultant of ClinicalAuditing.com®, LLC, a private and independent clinical Quality Assurance consultancy firm located in New Jersey, United States.

Pascal has BS and MS degrees (Nursing and Physical Therapy) from the University of Paris, France. In addition, he obtained an abbreviated MBA from the Rutgers Business School and a certificate for Healthcare Compliance, Ethics & Regulation from the Seton Hall University School of Law.

Pascal is an ISO 9001:2000 certified Lead QMS Auditor.

With more than twenty years of international GCP auditing in the global QA department of Hoffmann - La Roche, Pascal's audit experience includes 260+ audits (215 as lead) of all stages of clinical trials (Phase I-IV) for compliance with FDA, ICH, MHRA, CONEP, ANMAT, EMA, and national GCP guidelines / regulations in a variety of therapeutic areas in 36 different countries throughout North, Central and South America, Europe, Ukraine, Turkey, Israel, Thailand, Korea, Japan, South Africa, New Zealand, and Australia.

Pascal's expertise is in conducting domestic and international QA audits covering all aspects of the clinical research business including:

Investigator sites, pre-FDA and local health authority inspections, Contract Research Organizations (CROs), Clinical Pharmacology Units (CPUs), Site Management Organizations (SMOs), worldwide Sponsor Affiliate Study Management, domestic and international clinical projects.
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