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
- 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:
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
Our Trainings and Webinars
202503GCP- Overview of Good Clinical Practice (GCP)
Launch Date: March 17th, 2025-3-hours-Self-Paced-review of the ICH GCP E6 Guideline for good Clinical Practice (GCP)
$219.00
202504CRA-Clinical Research Associate (CRA) Training
Launch Date: April 14th, 2025-40-hours- Self-Paced with Webinar-introduction to clinical research and the job functions and responsibilities the Clinical Research Associate (CRA) for drug, biologic, and device clinical trials.
$1,699.00
202505GAU- Basic Quality Assurance Auditor Training
Launch Date: May 19th, 2025-40-hours-
$1,999.00
202506ISA- Advanced Quality Assurance Auditor Training- Investigator Site Focused
Launch Date: June 23rd, 2025-30-hours-
$1,999.00
202507VEN- Advanced Quality Assurance Auditor Training- Vendor Focused
Launch Date: July 21st, 2025-30-hours-
$1,999.00
202508SPO- Advanced Quality Assurance Auditor Training- Sponsored Focused
Launch Date: August 25th, 2025-30-hours-
$1,999.00
Contact
Alia Legaux
D.H.Sc., M.Ed., MCHES, CCRP
Independent Clinical Research Consultant
Email: Alia@4CRSC.com
Phone: (504) 931-7144
Fax: (866) 615-3655
https://www.4CRSC.com