Quality assurance for clinical studies the world over is a critical function. It takes on a greater level of importance when such studies are conducted in a distant country. Our Quality Assurance (QA) group functions autonomously and reports directly to the Chief Executive Officer to ensure independence and executive support.

Infinitus assists sponsors and sites with their quality assurance. We have comprehensive Standard Operating Procedures(SOPs) covering clinical trial operations and related processes, and assist sponsors in identifying any procedural gaps they may have, writing and updating sponsor SOP’s where required.

Infinitus conducts and manages independent reviews and audits of clinical trial investigator sites, research groups, data management audits and sponsor clinical operations, to ensure compliance with Good Clinical Practice (ICH-GCP), FDA, EMEA and local regulatory standards as part of clinical trial services.

Internal Quality Assurance

In keeping with the Infinitus philosophy of Kaizen, internal audit is conducted by its qualified auditors to ensure compliance to ICH-GCP across all functions.

The QA Team is responsible for updating, maintaining and ensuring adherence to the company’s SOPs.