GCP-Audits

 

Systematic audits are essential for the success of drug approval. They ensure that data from clinical trials are reliable and subjects' rights are protected. By identifying and solving arising problems at an early stage, audits can help you to save time, energy and costs. 

The independent proinnovera Quality Assurance team offers comprehensive audit services throughout Europe. Our auditors assess the compliance with ICH-GCP, your protocol, Standard Operating Procedures and country-specific requirements.

On the basis of the detected deficiencies our experienced auditors provide valuable recommendations that will significantly improve your study performance.

 Audit Preparation and Conduct

  • Audit Plan
  • Audit Report with Grading of Observations
  • Recommendations for Improvement
  • Corrective Action Plan
  • Audit Certificate

 Audits

  • Investigator Site Audits
  • System Audits
  • In-house Audits / TMF Audits
  • Vendor Audits

 Audits of Study Documents

  • Protocol
  • Informed Consent Form
  • Case Report Form
  • Clinical Study Report

Professionally reviewed study documents can reduce the time for approval and therefore have a positive impact on your study milestones.

 ... and more Services

  • Preparation and Review of SOPs
  • Training in GCP Requirements

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