Clinical Auditing 

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. 

Audits can be requested for very diverse reasons, e.g.:

  • As a routine part of the sponsor’s quality assurance program
  • To assess the effectiveness of the monitoring activities
  • In case of serious or repeated protocol deviations or suspicion of fraud
  • In preparation for inspections at sites and sponsor
  • When requested or suggested by regulatory authorities

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.

Qserve can perform all types of audits tailored to your expectations. Among others we offer:

  • Study site audit
  • Sponsor internal audit
  • CRO audit
  • Subcontractor audit
  • Trial master file audit
  • Inspection readiness audit

Want more information? Get in touch with us

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