Security and Compliance
Built for trust, ObvioGo offers the security and visibility needed to support compliance and inspection readiness throughout the trial.
Built for trust, ObvioGo offers the security and visibility needed to support compliance and inspection readiness throughout the trial.
ObvioGo is engineered to support global data protection and clinical compliance standards from day one. Role-based access and consent controls ensure appropriate permissions and privacy protections at the user, site, and study level.
Every action on the platform is automatically tracked in an audit trail, enabling full traceability and inspection readiness. The system enables studies to be compliant with HIPAA, GDPR, and 21 CFR Part 11, while enterprise-grade cloud infrastructure ensures security at every layer—from data encryption to hosting reliability.
Precision matters in clinical research. ObvioGo lets you assign roles, mask PII, and restrict access—so sensitive data stays protected and only the right people see what they need, when they need it.
Forget scrambling to prep for inspections. ObvioGo automatically tracks every action—time-stamped, user-linked, and traceable—so your trials are always audit-ready without the heavy lift.
Run global trials with confidence. ObvioGo is designed to enable compliance with HIPAA, GDPR, and 21 CFR Part 11—making it easier to keep your data audit-ready without the heavy lift.
“ObvioGo’s built-in access controls, consent tracking, and audit trail support customers’ efforts to design and conduct compliant clinical studies.”
— Senior Director, Quality and Compliance, ObvioHealth
ObvioGo enables study teams to configure permissions at the user, site, or study level. These role-based controls ensure that only authorized users have access to specific data, reducing the risk of errors and breaches. Consent tracking is also built into the platform, with masked PII to help maintain participant privacy and meet global data protection regulations.
The platform automatically captures every action performed across the system, including data entry, task completion, and participant updates. Each event is time-stamped and attributed to a specific user, creating a robust audit trail that ensures complete traceability. These logs are inspection-ready and help support both internal monitoring and regulatory reviews.
ObvioGo is designed to meet international regulatory standards, including HIPAA, GDPR, and FDA 21 CFR Part 11. Compliance is embedded into both the platform workflows and infrastructure, allowing sponsors and CROs to confidently run global trials while adhering to region-specific data governance requirements.
The platform is built on enterprise-grade cloud hosting with end-to-end encryption, protecting sensitive data both in transit and at rest. ObvioGo’s infrastructure is designed to ensure uptime, access control, and resilience against data loss, offering peace of mind for organizations handling critical clinical trial data.
«Sabíamos que necesitábamos facilitar el estudio a nuestros pacientes. Teníamos el estrés adicional de iniciar este ensayo en el punto álgido de la pandemia. El sitio virtual de ObvioHealth brindó el apoyo que necesitábamos para nuestros pacientes, y su equipo de ciencia clínica nos brindó su experiencia sin la rigidez de un CRO grande».
