Clinical Auditing

We offer all forms of Auditing Services to review the quality of your Clinical Process and Data

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Services
Medical Device CRO

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.

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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.

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

How can we help you? Contact us

Clinical Auditing