Good Clinical Practices (GCP)

Good Clinical Practice – Domestic and International GCP Audits

ClinAudits employs a team of subject matter expert consultants for regulatory compliance auditing projects of all sizes and scope. Our more than 57 auditors are regionally based throughout the U.S., Canada, South America, Eastern/Western Europe, China, India, Israel, Russia, Australia, Malaysia/Singapore and Japan. For all projects, our team employs quality control measures and follows appropriate SOPs to ensure that our work meets each client’s high standards.

Globally experienced, we have conducted audits in Europe (East and West), Australia, New Zealand, Russia, China, Asia, Canada, Mexico, South America (Chile, Argentina, and Brazil), Latin America, the Caribbean, India, South Africa, Israel, and the United States.

Over the past 20-plus years, ClinAudits has amassed competencies a broad range of therapeutic areas including oncology, infectious disease, respiratory disease, central nervous system (CNS), virology, cardiovascular, ophthalmology, and dermatology in Phases I through IV of clinical research.

Good Clinical Practices (GCP) – Audit Types

Domestic and International Clinical Research Trial Audits – established expertise in Good Clinical Practices (GCP) auditing to comply with FDA/EMA/MHRA regulations and other government regulatory authority regulations/guidelines, International Congress on Harmonization (ICH) Guidelines, specific company SOPs/guidelines and local governmental regulations/guidelines.

Contract Research Organization Audits – expertise in auditing CROs for sponsor’s pre-qualification consideration and post-capability CRO study management/ CRO managed studies.

Central/Specialty Laboratory Audits – tracking clinical trial laboratory specimens through the laboratory environment to check for compliance with GCP and GLP, if needed.

Clinical Trial Supply/Drug Depot Audits – auditing all aspects of clinical trial supplies in accordance with FDA/EMA/MHRA, GMP, GCP and ICH regulations/ guidelines and other governmental regulatory authorities.

Institutional Review Board Audits/Ethical Committee – perform audits of IRB’s (commercial, academic, private and hospital) and EC’s in accordance with FDA/ OPHR guidelines/regulations and other international, local regulations/guidelines.

Audits of Final Study Reports/NDA submissions/Safety Reports/IND updates – audits of database in comparison to reports/ submissions to FDA or other governmental authorities.

Adverse Event Reporting System/Pharmacovigilance Audits – process audit of AERS, SAES, IND Safety report procedures within a country or between countries/ subsidiaries.

Computer Systems Validation Audits – process audit of software and hardware for GCP, GMP, GTP or GLP settings to guarantee security and consistency of data.

System/Process Audits, e.g., Mock-FDA, EMA, MHRA and other governmental authorities audits, electronic submission audits, clinical operations and monitoring, data entry and data management, biostatistical, and medical writing departments.

Training of Quality Assurance and Clinical Research Personnel – customized training to your SOPs.

A sampling of our training services includes:

• Review of the History and Process of Clinical Research
• Review of Clinical Research Terminology
• Review of the Code of Federal Regulations and FDA Information Sheets
• Review of the International Conference on Harmonization (ICH) Guidelines and Essential Documents Needed for Clinical Research
• Clinical Trial Designs
• Responsibilities of the Investigator
• Responsibilities of the Research Coordinator
• Responsibilities of the Sponsor
• IND Studies, FDA/NIH Funded Studies
• Monitoring Requirements and Sponsor Visits
• Informed Consent Process and the Informed Consent Document – (e.g., assent and pediatric studies
• Recruitment and Advertisement for Patients
• Financial Disclosure
• Investigator Misconduct
• Test Article Accountability
• Adverse Events, Serious Adverse Events and IND Safety Reports
• Protocol Issues
• Medical Device Studies
• Data Collection, Source Documentation and CRF Design and Completion
• Preparation for FDA Inspections
• Current Trends and Findings in Clinical Research Trials- An Auditor’s Perspective
• Data Integity