Good Clinical Practice Audit

GCP Auditors conduct a good clinical practice audit to ensure your trials will be completed on time and right the first time and avoids warning letters. They also provide third-party verification that good clinical practices (GCP) are followed. GCP is an international quality standard that is provided by International Conference on Harmonisation (ICH) to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. GCP guidelines include protection of human rights in order to protect subjects and volunteers in a clinical trial. Good clinical practices, along with good agricultural practices, good laboratory practices and good manufacturing practices, are overseen by regulatory agencies in order to protect the health and well-being of consumers.

Good Clinical Practice Audit will:

Provide audits anywhere in the world. We will identify the right auditor that is closest to the site to be audited to keep your
expenses low. We can offer scheduled audits or surprise audits. We can provide the following types of GCP Audits

• Clinical Research Organization (CRO) GCP Audits
• Investigator/Study Site GCP Audits
• Vendor GCP Audits
• Institutional Review Board GCP Audits
• GCP Inspection Readiness
• GCP Audits of Phase I Units

Six reasons to use our Certified GCP Auditors

Our staff members are member leaders in ASQ, giving us a deep understanding of quality and auditing.
GCP Auditors provide third-party verification to ensure compliance with regulatory bodies around the world.
GCP Auditors ensure your trials will be completed on time and right the first time and avoids warning letters and the
resultant bad publicity.
We promote ethos, dedication and ethical behavior across industries. Only by maintaining ethical behavior will an
auditor deliver true value for the client.
Your GCP auditors will have years of experience training, consulting and auditing diverse companies in your industry.
You will receive a successful, satisfying outcome. Throughout the process, you will have direct access to our CEO to address your concerns.

To schedule your good clinical practice audit (cGCP audit) use the contact form on this page.

Interested in working with us? Reach out below.