Compliance & Trust
Built for regulated clinical research.
TrialBridge is designed to support secure, compliant, and auditable clinical workflows. Our platform combines modern security practices with features aligned to regulatory expectations across clinical research.
Regulatory Alignment
Supporting global clinical requirements
TrialBridge provides system controls commonly required for regulated clinical studies. Compliance is achieved through a combination of platform capabilities, customer configuration, validation, and operating procedures.
21 CFR Part 11–Ready
Platform features designed to support electronic records and electronic signatures in regulated studies.
- Immutable audit trails
- Role-based access controls
- Electronic signature workflows
- Secure record retention
ICH-GCP–Aligned Workflows
Designed to support Good Clinical Practice expectations across sponsors, CROs, and investigative sites.
- Role separation and oversight
- Traceable data changes
- Study-level governance
GDPR & Privacy Readiness
Data privacy principles are embedded into system design for global studies.
- Data minimization
- Access logging
- Support for DPAs and SCCs
Security & Assurance
Enterprise-grade security foundations
TrialBridge follows industry-recognized security practices and continuously improves its control environment as the platform scales.
SOC 2 Type II
Security, availability, and confidentiality controls designed to meet expectations for SaaS platforms.
HITRUST CSF (Roadmap)
Alignment with the HITRUST Common Security Framework to meet healthcare industry security expectations.
Secure Cloud Infrastructure
Hosted on modern cloud infrastructure with encryption, monitoring, and resilience controls.
Validation & Transparency
Supporting sponsor-led validation
Sponsors remain accountable for validation. TrialBridge supports this process with documentation and repeatable validation artifacts.
Validation-ready platform
We provide structured documentation to help sponsors validate TrialBridge within their quality systems.
- IQ / OQ / PQ templates
- Requirements traceability
- Release documentation
- Change control summaries
Clear, defensible compliance claims
TrialBridge avoids overstatement. We focus on transparency so customers can confidently assess fit for their regulatory environment.
Compliance outcomes depend on system configuration, validation execution, and customer SOPs.
Ready to build with compliance in mind?
Start your clinical trials on a platform designed for regulatory compliance and data security.