The primary function of OCT Quality Assurance Department is to guarantee that all procedures and activities related to the conduct and performance of clinical trials comply with the corresponding requirements and norms (GCP, local regulations, etc.). The QA Department is also responsible for the internal normative policies at OCT.
OCT Quality Assurance team takes the lead in maintaining SOPs, conducting audits of sites and subcontractors, implementing OCT training policy.
Quality Assurance Department coordinates all activities to ensure that trials conducted by OCT on behalf of our clients always precisely follow strict regulatory guidelines and global quality standards.
OCT auditors have a good command of local and international regulations and standards.
Our Head of Quality Assurance, Maria Zaytseva, is a certified BARQA Member.
Maria possesses 10 years of auditing experience and 13 years of industry experience.
OCT Quality Assurance team have performed audits for a wide range of medical indications and in all phases of clinical trials.
Our QA Department provides a full range of GCP audit services and produces comprehensive reports and audit certificates in accordance with the applicable norms and client specifications.
OCT provides the following Quality Assurance Services:
- Investigator site audits
- Trial master file audits
- Drug depot audits
- Vendor quality systems audits
- Central laboratory audits
- Preparation for regulatory inspections
