Proactive risk and compliance audits of your protocols, procedures, and activities.

At CRSC, our mission is to protect human subjects while ensuring the safety and efficacy of clinical trial product. 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. Through quality systems-based audits, we focus on proactively identifying risks and non-compliance that threaten 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.
  • Training records
  • Record storage
  • OSHA requirements
  • Mock FDA inspections
  • Assessing monitoring effectiveness
  • GCP training
  • Source documentation
  • Adverse event reporting
  • Drug or device accountability
  • Protocol violations
  • Clinical investigator oversight
  • IRB, Sponsor, and CRO communication
  • Laboratory data collection process
  • Financial disclosure requirements
  • Regulations and standards

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:

  • Data study (Trial Master Files/Site Master Files)
  • Audit of essential documents for specific studies
  • 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

Contact CRSC to get started

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