Is Your Informed Consent Process Truly Compliant?
Partner with Experts in GCP Auditing to Protect Your Trial Integrity.
In clinical research, informed consent is more than a signature, it’s a cornerstone of ethical and regulatory compliance. Yet, many organizations unknowingly expose themselves to risk due to outdated, inconsistent, or non-compliant consent procedures.
At ClinAudits, we specialize in Good Clinical Practice (GCP) audits with a sharp focus on the informed consent process. Our auditors are industry veterans with deep knowledge of ICH-GCP, FDA, and EMA expectations, and a keen eye for identifying gaps that can jeopardize patient rights, trial data, and regulatory approval.
🔍 What We Assess
- Accuracy and completeness of informed consent documents.
- Version control and tracking of consent forms.
- Compliance with regulatory and IRB/EC requirements.
- Proper documentation of consent discussions and re-consent.
- Investigator and site staff training on the consent process.
- Cultural and language appropriateness for target populations.
✅ Why Choose Us
- Risk-based approach tailored to your protocol, population, and phase.
- Detailed findings reports with practical, actionable recommendations.
- Training and remediation support for post-audit.
- Global Reach with region-specific regulatory expertise.
- Proven track record with sponsors, CROs, and investigator sites.
📈 Ensure Every Signature Counts
Whether you’re preparing for an FDA inspection, submitting to the EMA, or just want peace of mind that your sites are compliant, ClinAudits brings clarity, confidence, and compliance to your informed consent process.
Interested in learning more about GCP auditing? Stay ahead of regulatory expectations with expert training and audit support. Contact us today! ClinAudits, LLC- Cheri Wilczek, President-email: cheri.wilczek@clinaudits.com; phone: 973 492 8108 extension 111. Our website is: www.clinaudits.com.
WHO WE ARE
ClinAudits is a highly specialized third-party provider of auditing and Consulting services in the areas of:
Good Clinical Practice (GCP)
Good Laboratory Practices (GLP)
Good Manufacturing Practices (GMP)
Good Pharmacovigilance/Drug Safety (GPV)
Good Tissue Practice (GTP)
Risk Evaluation and Mitigation Strategy (REMS)
Since 1999, ClinAudits has completed over 6,000 projects, and we have Grown to over 106 active consultants worldwide!