Quality Assurance

The Quality Assurance Unit is an independent unit within the company. It assures that clinical trials are planned, conducted and reported in compliance with regulatory requirements, Standard Operating Procedures (SOPs) and ICH Guidelines. The unit assists, guides and controls all quality aspects of the clinical trials from the early study outline to the final reporting of the trial results.

The Quality Assurance Unit provides the following services:

• Independent clinical trial audits
• System audits
• Database audits
• Clinical study protocol audits
• Clinical study report audits
• Pre-inspection audits
• GMP audits
• GLP audits
• Professional quality assurance advice on an ad hoc basis
• GCP and quality assurance presentations at investigator meetings
• Writing global and local SOPs for clients