QUALITY ASSURANCE

Outstanding Quality

The Cesta Quality Assurance team ensures compliance with standards of good clinical practice and good laboratory practice.

Good Clinical Practice (GCP) Audits

Our experienced auditors follow FDA and ICH regulations and guidelines to ensure consistent audits across global trials. Our auditors work closely with each client to develop and implement audit plans that utilize and comply with the client’s Standard Operating Procedures (SOP).

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• Assisting with creation of SOPs and WIs

• Preparation of essential document review guidelines

• Investigator site audits to verify the accuracy of the data being submitted to the sponsor and to ensure the site is complying with the protocol, regulations, and guidelines

• Protocol and Informed Consent Form reviews for compliance to GCP and SOPs

• Database audits

• Final report audits

• Sponsor/monitor/CRO audits

• Institutional Review Board/Independent Ethics Committee audits

• Review of key deliverables (protocols, reports, datasets, etc.)

• Compliance and auditing services include vendor and site audits

• Preparation of investigators for regulatory authority audit

Good Laboratory Practice (GLP) Audits

• Protocol reviews

• FDA-mandated audits of in-life study procedures

• FDA-mandated final report audits

• Facility audits