Clinical Audits

Auditing is a valuable tool to get an overview of the performance and quality processes of your clinical trial site to ensure data quality and inspection readiness. Collaboration and delegation of tasks between the sponsor and the clinical site is common in clinical trials. However, as a sponsor, you have a duty to stay on top of things and take responsibility for regulatory compliance, ethical behaviour and the quality and integrity of your clinical data.

Clinical audits are  performed to assess a clinical site’s qualifications and capabilities to manage a Clinical Investigation Trial in compliance with EN ISO 14155 and all applicable national  international regulations and guidelines.

Clinical audits are also performed to evaluate compliance with the study protocol / clinical investigation plan and the study procedures according to the current national and international regulations and guidelines.

A clinical audit can cover all or some of the involved parties, systems and facilities and is performed independently.

Reasons for Clinical Audits

Audits can be requested and conducted for different reasons:

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

Type of Clinical Audits

TRIQ can perform all types of clinical audits:

  • Sponsor Internal Audit
  • CRO Audit
  • Trial Master File Audit
  • On-Site Audit
  • Inspection Readiness Audit

Why you choose TRIQ

We strongly believe that TRIQ can provide you with an independent and systematic overview of Clinical Investigation Study compliance and data quality by auditing Clinical Investigation Trials or external and/or internal processes. We provide clear and accurate audit reports and can assist in the development and implementation of corrective and preventive actions (CAPAs) if required.

Our auditors have many years of clinical experience in all types of audits. We have conducted more than 100 national and international audits.

Need More Information ?

If you have specific questions or want to know what TRIQ GROUP can do for you then please contact us.