Rekha Pai is an experienced Quality Assurance Professional with wide ranging experience conducting GCP audits within all clinical phases in CRO and Pharmaceutical Industry. She has over 12 years of experience in developing and implementing Quality Management Systems within all phases of Clinical Development and has conducted over 100 investigator site audits (USA, South America and Asia) covering a wide range of therapeutic areas. Additional areas of expertise include conducting Vendor Audits (CROs, Phase I Units, Pharmacokinetic laboratories), Trial Master File (including e-TMF) audits, Investigational Product Management/Distribution system audits, Independent Data Safety Monitoring Board audits and SOP administration including advice on procedure system establishment, refinement and SOP development.
Ms. Pai has a degree in pharmacy, a certification in Post-Marketing Safety Surveillance from Temple University (QA/RA Program) and has obtained certification as a Registered Quality Assurance Professional – Good Clinical Practices (RQAP-GCP) from the Society of Quality Assurance Council on Professional Registration. She is delighted to be a consultant with ADAMAS Consulting.