Clintrac’s quality assurance services are to provide quality and integrity in all aspects of clinical trial. The QA team is well trained in regulatory guidelines as well as has adequate knowledge in GCP & GLP. We ensure documentation and reporting data in compliance with ICH-GCP Guidelines.

The QA personnel ensure high standard in all activity and execution process. We play a major role in all stages from site initiation to data base lock to ensure the compliance with ICH-GCP and other applicable regulatory guidelines. Our team provides routine training to keep all study personnel updated with latest developments, ensuring uniformity and consistency by implementing process standardization at all levels. We also ensure document control and overseas organizational training with stated objectives. All study data & reports are properly archived with limited access controls.

Standard Operating Procedures: 

We have developed SOP's for the areas like,

Quality Assurance Audits: 

Our team provides QA audit services for the following: