It is essential that an organization that conducts human subject research follows SOPs, Federal, State, and industry policies and regulations. One way to ensure that the clinical trial process is reliable is to initiate an independent audit and/or inspection during the trial.

The clinical research team should be prepared for an audit at any time. Our professional ICRS team provides an independent appraisal of the quality of the data and compliance with set rules and regulations.

ICRS offers qualifying audits for Contract Research Organizations (CROs) and independent Principal Investigators

• Data Management
• Documents review:
•   Research charts
•   Consents
•   Regulatory documents
•   Source documents
•   others
• GCP audit:
•  Routine
•  Pre-trial
• Ongoing trials
• End-of study
• OSHA

ICRS specialists also offer OSHA compliance inspection to CROs, medical offices, labs, private practices, and other healthcare professional settings.