Quality & Compliance
The Quality Assurance (QA) department is an independent division within Clinlogix that works to ensure compliance with the protocol, SOPs, and regulatory guidelines to ultimately ensure research subject safety as well as the integrity and validity of study data.
Quality and compliance assessments of the services we offer is provided by the QA department through conducting various types of audits at multiple stages throughout the clinical development process we support. This enables early detection of potential problems and allows for intervention and implementation of appropriate corrective/preventative action, when necessary.
The Clinlogix Quality Assurance team provides:
- Regulatory training, as applicable to Clinlogix personnel and site staff, in the areas of International Conference on Harmonization (ICH)/ Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP).
- Internal system audits of study-related systems and procedures.
- Hosting of Sponsor Audits and Regulatory Inspections of Clinlogix offices.
- Standard Operating Procedure (SOP) oversight.
- Facilitation of continuous improvement through management of the Corrective and Preventative Action (CAPA) program.
- Investigative Site Audits to provide monitoring activity oversight.
- Vendor Audits of service providers.
- Support for site preparation for Regulatory Inspection.
Clinlogix can perform many of these same QA support services for you, following your procedures or ours, including:
- Investigative Site Audits.
- Vendor Audits.
- Internal System Audits.
- Regulatory Training.
- Regulatory Inspection Preparation.