Auditing is a valuable tool to gain insight into the performance of your vendors, confirm you have oversight and assure inspection readiness. Collaborations and delegation of tasks among several stakeholders is common in clinical trials. However, as a sponsor you have the obligation to keep oversight, and to take responsibility for regulatory compliance, ethical conduct and the quality and integrity of your clinical data.
Clinical audits are performed to evaluate compliance with the protocol, the procedures, International Standards and the applicable regulatory requirements. An audit can cover all or some of the involved parties, systems and facilities and is performed independent of, and separate from, routine monitoring or quality control functions.
Qserve as Medical Device CRO
Qserve CRO is fully medical device dedicated and aims to be as lean as possible, avoiding unnecessary administration and bureaucracy. Our clinical team gained experience working at Notified Bodies, CRO’s and Sponsors/Manufacturers. This combination of backgrounds, combined with Qserve’s in-depth knowledge of clinical and regulatory affairs will offer you a comprehensive, objective, and compliant audit.
We truly believe in a strategic, notified body-proof and practical approach. Auditing your vendors, external- and/or internal processes by Qserve auditors gives an independent and systematic overview of the study compliance and the data quality. We provide clear and concise audit reports and can help write and implement corrective and preventive actions (CAPAs) when needed.