Auditing & Compliance
Finally, Being Audited Pays Off.
With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. IMARC provides the specialized independent auditing support services you need to survive today's rigid regulatory requirements — not only to ensure compliance, but also to protect patients.
Approvals are not just granted. They are earned. IMARC has experience preparing even the most sophisticated sites – domestically and worldwide – for FDA and International inspections. That includes everything from compliance checks and coaching – to – regulatory reviews, organization of documents, and more.
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Prepare for Approval
- Identify and fix issues before the FDA finds them.
- Get ready for inspections by knowing what to expect.
- Address compliance concerns and gain reassurance
through Special Request Audits. - Verify that vendors have the experience to do their jobs.
- Prep your team with interviewing and coaching sessions.
Auditing Services that will Pass Your Inspection
Site GCP Audits
Utilizing FDA's BIMO checklist as a starting point, IMARC
Auditors identify, analyze and strengthen weakness in
compliance areas, including:
- Regulation
- Protocol
- IRB Requirements
- Agreements
- Sponsor Requirements / SOPs
- Internal Site SOPs
SPONSOR/CRO Audits
Regulatory inspection preparation, including evaluation of:
- Organization & Personnel
- Monitoring Activity
- Quality Assurance
- AE Reporting
- Data Collection & Handling
- Electronic Records
- Product Accountability
Vendor Qualification Audits
Evaluation of vendor capabilities and performance, including:
- Overall Organization
- Personnel Qualifications & Training
- Standard Operating Procedures
- Records Maintenance
- Facilities / Equipment
For additional information on IMARC Research’s auditing and compliance services, please contact John E. Lehmann at 440.801.1540.
