PROACTIVE RISK AND COMPLIANCE AUDITS OF YOUR PROTOCOLS, PROCEDURES, AND ACTIVITIES

Our auditing goal is to protect human subjects while achieving clinical trial product safety and efficacy objectives. CRSC accomplishes this through quality systems- based audits that focus on proactively identifying the risks and non-compliance which compromise patient safety, data integrity, and product efficacy.

We can independently assess your compliance level while also providing valuable recommendations for improvement.

No matter whether auditing against your protocols, standard operating procedures, industry specifications, or regulations, CRSC has experience in three primary sides of compliance:

• The US Food & Drug Administration- Consumer Safety Officer/Investigator
• Major US Pharmaceutical/Medical Device Manufacturer-Senior Clinical Research Associate

• Independent GCP Auditing-Having completed numerous Sponsor, CRO, IRB, and Investigator Audits.

GCP Auditing techniques and scope

• Data Trending
• Informed Consent
• Training Records
• Regulatory Documents
• Case Report Forms
• Facility Inspection
• Record Storage
• OSHA Requirements
• Mock FDA Inspections
• Assessing Monitoring Effectiveness
• GCP Training
• Source Documentation

Clinical Research GCP Auditor

The role of a CRSC GCP

Auditor involves the review and compliance verification of quality systems throughout the clinical development process, from the design of the protocol to the final clinical study report. Overall, the GCP Auditor conducts a variety of different types of audits, which usually include:

Study (Trial Master Files/Site Master Files)

• Audit of essential documents for specific
• Audit of sample investigator
• Audit of contract research
• Central laboratories and other specialist facilities.
• Computer systems validation
• Audit of software
• Database audits
• Clinical study report audits
• Regulatory submission audits