Gualberto Perez MD, LCMT, CCRC, CPI
CEO, Founder and President, GCP Research
| SUMMARY OF QUALIFICATIONS • 22 plus years of experience in the clinical, medical, scientific and regulatory drug and device development in various therapeutic areas in phase I-IV R&D. • Sixteen years of Successful Management experience at the executive suite level in the pharmaceutical industry (CRO/Clinical Research Organization and Clinical Site level in Phases I-IV). • Fifteen years of Experience in the clinical laboratory management of CLIA, COLA and CAP certified laboratories dedicated to clinical research trials. • Experience in designing pre- and post-approval clinical strategies and study protocols in pediatrics, diabetes, renal impairment, hepatic impairment, CAD, women’s health and hormone replacement therapy products, contrast agents and devices. • Experience in designing clinical PK strategies and study protocols in a comprehensive full service approach. • Fluent in English and Spanish language. • Commissioned Public Notary State of Florida • Thorough understanding of Good Clinical Practices and ICH Guidelines, Certified for over 12 years as a CCRC by the ACRP. • Experienced lecturer of Good Clinical Practices, Good Documentation Practices and Good Laboratory Practices, overall all Quality Assurance Auditor and lead. |