01. GxP Audits and Quality Assessments
Independent audits and assessments to help you understand compliance risks and make informed quality decisions.
- Clinical Trials and GCP: Investigator-site, sponsor, and CRO audits across Phase I–IV clinical trials and patient PK/PD studies, including study-specific assessments.
- BA/BE and GCP: Audits of BA/BE centres and CROs, study-specific assessments, and reviews of sponsor oversight.
- Laboratory Quality: Assessments of clinical, central, bioanalytical, preclinical, and in-vitro laboratories, including bioanalytical method-validation documentation and supporting data.
- Pharmacovigilance Quality: Audits of pharmacovigilance systems, processes, and service providers.
- CDM and Biostatistics: Functional-system and study-specific audits of data management and statistical activities.
Support also includes vendor assessment and qualification, quality due diligence, and audit programme management.
