Audit objectives:
Assess the safety and security of research participant protection and the reliability of clinical trial results.
Assess protocol compliance, study-specific procedures, relevant Good Clinics Practice guidelines (ICH E6 (R2) and applicable regulations.
Customer Demand:
The entire process takes place according to the main focus of each audit and customer needs and as agreed in meetings.
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Summary of qualifications and experience
- Member of Society of Quality Assurance: Home to the World's best QA Professionals
-Internationally qualified independent auditor by Italian Company.
-Internationally qualified independent auditor by SQA Services, Inc. Global Quality Assured for ICH GCP E6(R2), ISO 9001:2015, ICH Q9, Pharmacovillence/Adverse Events.
-Independent audit experience in COVID-19 study.
-Independent audit experience in Rare Disease study.
-Experience in Pharmaceutical Industry as Quality Specialist and Audits in Clinical Research.
-Experience in Research Center Management.
-Top recruiter Global Dapa CKD Study.
-Experience in Clinical Research since 2011 in clinical studies of Cardiology, Endocrinology,
Gastroenterology, Gynecology, Nephrology, Dentistry, Ophthalmology, Orthopedics,
Pulmonology, Vascular, pain improvement assessment.
-Experience as Reporting Member of the Research Ethics Committee of FMABC.
- Postgraduate in Clinical Research by Invitare Pesquisa Clínica, 2012.
- Graduated in Biomedicine from the Universidade Metodista de São Paulo, 2011.
- Started 3 Clinical Research Sites since your foundation.
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