Pattern’s platform is trusted by biopharma, CRO, and academic customers to conduct clinical studies of all kinds, from single-site research to global phase IV clinical trials. We implement and maintain industry-standard measures that ensure regulatory compliance, secure and quality data, and privacy.
For more detailed information on compliance at Pattern, please contact us.
Secure and Stable Platform
Data security is a top priority at Pattern. We meet or exceed the latest security standards and frameworks and undergo numerous assessments and audits to constantly improve and protect data against threats. We are HITRUST Certified and are in the process of FISMA authorization. This secure foundation is coupled with a scalable and stable cloud-hosting environment to ensure customer data is always accessible. Additionally, we are experienced with multiple vendor risk management platforms and can quickly transfer our audit reports for quick and easy onboarding.
Participant Privacy Protection
and Data Safeguards
Pattern’s systems are designed to ensure oversight and accountability regarding data integrity and participant privacy. We track U.S. state-based privacy laws, 15+ international privacy laws, GDPR, and HIPAA and monitor for new laws daily. We also understand the importance of data-specific privacy laws, such as those regarding children or substance abuse, and the care needed to ensure and demonstrate compliance in the U.S. and internationally.
Compliant, Inspection-Ready Systems
Quality underlines everything we do. Pattern maintains a transparent, inspection-ready, Part 820-based Quality Management System that ensures high-quality standards and assures compliance with regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and FDA/ICH GCP E6(R2). Our Agile SDLC and comprehensive automated testing processes are aligned with modern best practices and the latest guidance from FDA Computer Software Assurance (CSA), ISPE GAMP 5 2nd edition, and Annex 11 planned revisions. Our internally verified, process-controlled, configurable SaaS platform and program validation services enable efficient client validation and change management.
We Go the Extra Mile to Ensure Security, Privacy, and Compliance
Pattern Health has been HITRUST Certified since 2016. The HITRUST Certification is healthcare’s gold standard for information security, privacy and compliance. HITRUST is a comprehensive overlay of industry-relevant regulations and standards: NIST RMF (Risk Management Framework), CsF (Cybersecurity Framework), ISO 27001, NIST SP 800-53, HIPAA, HITECH, and other sources. HITRUST certification requires advanced systems and expertise and is only awarded after independent auditing.
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Contact us today to discuss your needs and learn more about our platform.
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