Security, Privacy, and Regulatory Alignment
Enlighten Clinical Solutions maintains a comprehensive security and privacy program aligned with the regulatory and vendor due-diligence expectations of life sciences sponsors and CROs. Our program supports the secure management of clinical trial data across modern, cloud-based environments and is validated through independent audits and assessments.
SOC 2 Type II
Independent verification through recurring audit assessments.
SOC 2 Type II is a widely recognized audit used by life sciences sponsors and CROs to evaluate how technology providers protect sensitive data.
Enlighten’s SOC 2 Type II audit assessed the operation of security controls across an extended audit period, providing assurance that controls are consistently followed in practice, not just documented.
HIPAA Security
Independently assessed safeguards for healthcare and clinical research data, including incident response.
Enlighten has completed independent assessments of controls aligned with the HIPAA Security and Breach Notification requirements.
These assessments evaluated the design of administrative, technical, and physical safeguards used to protect electronic protected health information (ePHI) within applicable customer workflows and support sponsors’ and CROs’ healthcare data protection expectations.
GDPR Privacy Controls
Independently assessed privacy controls for personal data protection.
Enlighten has completed an independent GDPR assessment evaluating privacy governance, data protection processes, and controls supporting the processing of personal data.
This assessment helps support sponsors’ and CROs’ global privacy and data protection expectations when conducting clinical research.
Security, Privacy, and Compliance Program
Enlighten Clinical Solutions maintains a structured security and privacy program designed to protect clinical research data throughout the technology lifecycle. Controls are developed, implemented, and reviewed as part of an established risk management and governance framework.
This program supports accountability, consistency, and continuous improvement as the platform, customer base, and regulatory landscape evolve.
Continuous Security Oversight
In addition to periodic independent audits and assessments, Enlighten maintains ongoing security oversight to support the continued effectiveness of its controls. This includes centralized management of access controls, infrastructure security, logging and monitoring, incident management processes, and third-party vendor risk considerations.
Security and compliance activities are reviewed regularly and updated as part of Enlighten Clinical’s broader risk management and security governance program.
Supporting Secure Clinical Research Operations
Enlighten’s security and compliance program supports the secure operation of its clinical trial technology solutions, including EDC, eTMF, and CTMS. These solutions help sponsors and CROs manage clinical data, documentation, and operational workflows within secure, controlled environments while supporting customer-led validation and regulatory obligations.
Trust Center & Security Transparency
Enlighten maintains a public, high-level Trust Center to provide visibility into its security and compliance program. The Trust Center includes an overview of our security practices, audit posture, and approach to protecting clinical research data.
More information about Enlighten Clinical Solutions security and compliance is available through our Trust Center.
Security and compliance activities are reviewed regularly and updated as part of Enlighten Clinical Solutions’ ongoing security and risk management program.
Explore Resources from the ClinicalTrials.gov – A trusted database of clinical trials worldwide, supporting data integrity and regulatory compliance.