Regulatory Compliance

Certification is not explicitly mandated in EMA or MHRA regulations. However, EMA’s Reflection Paper on TMF and guidance from national regulators (e.g., MHRA, BfArM, ANSM) emphasize the importance of traceable document destruction and complete audit trails. As a result, certified copies and certificates of destruction are considered best practices to support inspection readiness.

“EU” refers to European regulatory best practices outlined by agencies such as EMA, MHRA, BfArM, and ANSM. The concept is not exclusive to the European Union. Certified Copies are recognized in both EU and FDA frameworks as part of inspection readiness. The earlier reference to “ET” was a typographical error and has been corrected to “EU.”

Yes. “EU” is the correct term and refers to European regulatory best practices related to certified copies and inspection readiness.

HITRUST (Health Information Trust Alliance) is a framework designed to help organizations manage data protection, information risk, and regulatory compliance, particularly in healthcare. Originally developed to support HIPAA compliance, HITRUST has since expanded to be used across multiple industries.

ISO 27001 is an international standard for managing information security. It provides a framework for establishing, implementing, maintaining, and continually improving an Information Security Management System (ISMS) across organizations of any size or industry.

Yes. ISO 27001 focuses on general information security management, while HITRUST includes additional controls specifically designed for handling sensitive data such as Protected Health Information (PHI). HITRUST is generally considered more comprehensive due to its inclusion of HIPAA and other regulatory requirements.

Yes. HITRUST builds upon ISO 27001 by incorporating industry-specific regulatory requirements such as HIPAA and GDPR, making it more suitable for organizations handling sensitive data.

HITRUST offers broader regulatory coverage and aligns more closely with industries managing PHI and other sensitive data. Prioritizing HITRUST demonstrates stronger compliance maturity and alignment with evolving regulatory expectations.

A Virtual Data Room (VDR) can be used to securely share compliance certificates and NDAs. VDRs provide access controls, audit trails, and permission management to ensure secure and traceable document sharing.

Trial Interactive is hosted on AWS, which operates SSAE 16 SOC 2–certified data centers. The application is managed according to Trial Interactive policies, including SDLC and Change Management procedures.

No. Trial Interactive operates as a Data Processor, while customers remain Data Controllers. No additional requirements are imposed beyond those assigned to data controllers.

TransPerfect continuously evaluates GDPR requirements. At present, no significant changes are anticipated. Customers will be informed of any identified impacts following assessment.

Yes. Trial Interactive provides the necessary system controls to support compliance with 21 CFR Part 11 for electronic records and electronic signatures.

Yes. Trial Interactive provides reporting capabilities that allow organizations to submit a single certification covering all applicable users, as permitted under 21 CFR 11.100.

Trial Interactive follows TransPerfect’s privacy policy, which outlines how customer data is processed and protected. The policy is accessible via a link within the application.

Trial Interactive uses a multi-tenant SaaS architecture that ensures complete logical separation of each customer’s data while providing scalability and security.

Yes. All documents are virus-scanned and encrypted both at rest and in transit.

Trial Interactive maintains controlled SOPs under QA governance. Employees receive mandatory training, and customers may review documentation in supervised audit settings.

Yes. Customers may conduct formal audits at corporate offices, while hosting audits are supported through standardized certifications such as SSAE 16 SOC 2 reports.