Challenge
An international clinical trial needed to collect data across multiple countries, each with its own regulatory regime and practical constraints. The team required a flexible system that could adapt locally while keeping data standardised and compliant.
Solution
OPORA Health provided a configurable data collection and consent framework that could be tailored to each jurisdiction. The platform ensured consistent data structures, robust audit trails and alignment with both the EU AI Act and local regulations worldwide.
Implementation
We deployed OPORA Core with region specific configurations, covering consent workflows, data handling rules and operational adjustments for local clinical environments. The system allowed coordinated global delivery without losing standardisation.
Governance and Compliance
OPORA Health’s governance layer tracked compliance across regions, monitored ethical considerations and provided a unified view of risks, safeguards and validation progress. Each requirement was linked to concrete data and workflow components.
Outcome
The trial team ran a harmonised yet locally compliant global study, accelerated ethical oversight and reduced regulatory friction, enabling smooth execution across all participating countries.