Snapshot 17910
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Trust & Compliance Clinical research demands rigor. Our platform meets all the regulatory and data security standards required for global trials. Compliance & Certifications ICH GCP E6 (R2) Compliant International Conference on Harmonisation Good Clinical Practice guidelines for designing, conducting, recording, and reporting clinical trials. 21 CFR Part 11 Compliant FDA regulation ensuring electronic records and signatures are trustworthy, reliable, and equivalent to paper records. HIPAA Compliant U.S. Health Insurance Portability and Accountability Act standards for protecting sensitive patient health information. GDPR Compliant European Union General Data Protection Regulation requirements for data privacy and security. SOC 2 Type II Certified Independent audit confirming our security, availability, and confidentiality controls meet industry standards. ISO 27001 Certified International standard for information security management systems, demonstrating systematic protection of data. Disclaimer: OpenClinica maintains current certifications through regular audits and assessments. For verification documentation or specific compliance questions, please contact us. Have a question? Contact Us Which Solutions would you like a quote for? eClinical Solutions Recruitment Solutions