Independent Audits are more effective,
due to the total impartiality in performing the function.
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.
Clinical Research Independent Audit Program
What is included in the procedure:
Planning, conducting audit activities (Clinical Research Sites, vendors, CRO).
Opening and closing meetings with Investigators and staff, managers, monitors and coordinators of Clinical Research Sites/CRO.
Conducting the audit based on experience and comprehensive understanding of all national/international regulatory requirements, including ICH and Good Clinical Practice(GCP);
Preparation, review and delivery of the audit report as agreed. (internal or Sponsor's SOPs)
Preparation, review and monitoring of the entire implementation process of corrective and preventive actions (CAPA).
Customer Demand:
The entire process takes place according to the main focus of each audit and customer needs and as agreed in meetings.
Summary of qualifications and experience
-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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