Quality Assurance

IN TRIAL & INDEPENDENT QUALITY ASSURANCE CAPABILITY

Quality Assurance in clinical trials is about protecting human subjects from research risk. GreenLight Clinical has dedicated, highly qualified quality assurance professionals who provide standalone audit services.

The scope of audits that can be conducted includes investigator site audits and vendor/ supplier audits. We provide independent QA services from experienced professionals across all clinical trial phases.

As well as being an integral part of our internal processes, GreenLight Clinical is able to provide a full range of independent Quality Assurance services from pre-clinical, through phase I to phase IV studies.

Available internationally, GreenLight Clinical’s clinical trial audit ensures high ethical standards of clinical trials are upheld and minimises risk to data integrity.

Our QA team is staffed by experienced professionals who operate independently from the personnel engaged in the management and conduct of clinical trials.

Quality Assurance services encompass all aspects of the clinical development process, including:

• Trial Master File Audits
• Investigator Site Audits
• Phase I Units Systems Audits
• Third-party vendors including archive facilities and Investigational Product management
• CROs Study Documentation e.g. Protocols, Clinical Study Reports
• Computer system validation reviews local, central and bioanalytical laboratories
• Database Audits GLP Audits
• Bioanalytical method validation quality system management
• Due diligence