Quality Assurance and Audit

Clinartis is a global clinical research organization providing a full range of independent GCP audit capabilities and quality assurance support.  Clinartis has developed proven systems approach methodologies for the conduct of investigator site, clinical research organizations, data management and analysis, central reading facilities, central laboratory facilities, software systems and drug supply management audits.   These services provide enhanced quality standards, optimize clinical trial effectiveness and minimize regulatory risk.  Our GCP audit experts cover the globe including: North America, Europe and India.  Clinartis performs GCP audits as per FDA 21 CFR requirements, ICH E6, ISO 14155, local regulatory requirements and standard operating procedures.

Clinartis performs the following clinical research audits in support of Phase I- III clinical trials:

Phase I Units

  • Pre-qualification audits
  • Critical study procedure audits in real time
  • Site/Study Audit

Investigator sites

  • Review of essential study documentation to assure compliance with ICH/GCP,  protocol specific requirements, all applicable regulations and SOPs
  • Review of study conduct at site, study supply accountability, the data collection, integrity and monitoring activities
  • Assess availability of source records and compliance with the protocol and GCP

Trial Master Files

  • Review of essential documents clinical trial documents focusing on the need to reconstruct the clinical trial at any point from complete and thorough clinical trial documentation.
  • Review in accordance with client SOPs and ICH GCP requirements

Clinical Study Report

  • Assessment of compliance with ICH E3, E9 and ISO 14155
  • Data verification against source data

Pre-Regulatory Inspection Audits/Gap Analysis

  • Review your processes, quality system, policies, practices and SOPs for compliance with the sponsor’s responsibilities for GCP
  • Report observations and suggest corrective and preventive actions
  • Assist with corrective and preventative actions in preparation for FDA or other health authority inspection.

Third Party Vendor Audits

  • Review and assess the GMP manufacture of clinical trial materials
  • Review and assess that proper blinding and labeling procedures are in place and being executed on.
  • Review and assess study supply management systems and logistics for compliance to storage and shipping conditions and accountability.
  • Independent audits to establish supplier’s ability to provide quality consistent with project specifications and contract requirements, ICH/GCP, applicable regulations and SOPs.