Our QA team ensures adherence to any applicable regulations from the FDA, Canada's Health Products and Food Branch Inspectorate, European Union, ANVISA (National Health Surveillance Agency Brazil) and other international agencies during each phase of the clinical trial process.
Our team ensures that we comply with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and International Conference of Harmonisation (ICH-GCP) guidelines (E6).
Our QA team measures, assesses and reports quality data and seeks ways to continually improve quality performance and results. According to industry best practices, our Corrective and Preventive Action (CAPA) process ensures we investigate significant out-of-specification events, deviations and discrepancies, report the findings and conclusions of the investigation and implement and document corrective actions. This is to ensure operational equipment is appropriately maintained and operating as defined.
Our senior-level auditors conduct unbiased assessments of all aspects of a study, including auditing clinical sites and associated databases, vendors, validating software, and assuring the quality of individual reports, study files, tables, and listings. They can also provide training to prepare investigator sites for actual regulatory inspections.
Our services include:
FDA Audit Inspection Preparedness Training
Clinical Site, Manufacturer Site and Laboratory Audits - GCP, GMP, GLP
Review of Clinical Study & Pre-Clinical Protocols, CRFs, and Study Files