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).
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
Final report 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
FDA-mandated audits of in-life study procedures
FDA-mandated final report audits