A SOC 2 Report is an independent assurance report evaluating a service organizationís controls related to security, availability, processing integrity, confidentiality, and privacy (Trust Services Criteria).
SOC 2 is highly relevant when vendors host or process regulated clinical trial data, including eCOA, EDC, eTMF, or safety systems. Sponsors and institutions use SOC 2 to support vendor qualification, cybersecurity risk assessment, and compliance due diligence. The report describes the control environment and includes testing results over a defined period (Type II) when applicable. SOC 2 evidence can strengthen confidence in data protection and operational reliability across study-supporting platforms.