GCP Compliance Audits
Assess the compliance of your clinical studies, investigator sites and vendors with GCP and applicable regulatory requirements.
Pharmaspecific conducts independent, rigorous GCP compliance audits to assess whether clinical studies, investigator sites and vendors comply with Good Clinical Practice (ICH E6), applicable procedures and current regulations. This process examines the practices, documentation and processes in place to identify any deviations and areas requiring particular attention.
Our methodical approach identifies risks, detects potential deviations and implements appropriate corrective and preventive actions (CAPA) to ensure lasting compliance with GCP requirements. Requirements are taken into account at every stage of the audit to support a structured approach to improvement and risk control.
Our audits also assess team practices, available documentation and how procedures are applied in the field. This analysis helps identify areas for improvement, prioritise the necessary actions and durably strengthen the quality and compliance of clinical activities.
Recognised expertise in GCP clinical audits
Our qualified, experienced auditors conduct objective, independent GCP compliance audits based on international standards (ICH-GCP) and applicable regulatory requirements. They assess the compliance of clinical studies, investigator sites and vendors, while identifying any deviations and points requiring corrective action. This approach strengthens risk control and supports lasting compliance of clinical activities.
Audits to prevent and improve
Our audits identify deviations, assess risks and recommend appropriate actions to strengthen process control, data integrity and participant protection. They also help assess the compliance of clinical studies, investigator sites and vendors with regulatory requirements and Good Clinical Practice. This approach durably strengthens the quality of practices and the compliance of clinical activities.
A trusted partner by your side
Our independence, responsiveness and knowledge of the regulatory context enable us to provide operational recommendations and tailored support at every stage of your projects. We also help you prioritise corrective actions, durably strengthen the compliance of your clinical activities and improve control of the risks identified during audits. Our support thus promotes a structured approach adapted to the specific challenges of each study.
Our services include
Secure the GCP compliance of your clinical studies
Our experts are available to discuss your needs and offer support tailored to your projects.