Services >> Clinical Quality Assurance

.........................................................................................................................................................................................................................................................................

Quality assurance for clinical studies the world over is a critical function. It takes on a greater level of criticality when such studies are conducted in India, which is often approached apprehensively as a source of quality clinical data. In the face of such perceptions, Roxaane set up its CQA group to address key client concerns.

In keeping with the Roxaane philosophy of continuous improvement, internal audits are conducted by its auditors to ensure compliance to ICH GCP across all functions. The Roxaane CQA group is the custodian of the Roxaane SOPs across all functions and is responsible for updating, maintaining and ensuring adherence within the company.

In Roxaane, the CQA group also functions as the initial training facilitator wherein all new employees are trained in ICH-GCP by this group. Individual contracts for investigational sites, central laboratories and other CROs are also taken up by our CQA group. The CQA group includes professionals with a background in clinical monitoring, auditing & development and implementation of quality systems