Step 8:
Un ensayo clínico es tan valioso como la fiabilidad de sus resultados. Los expertos en DCT de ObvioHealth saben cómo diseñar un ensayo para reclutar y capacitar a la cohorte óptima y eliminar el «ruido» estadístico, de modo que puedas obtener las pruebas sólidas que necesitas.
With a 20-year legacy in clinical research through our parent company, SPRIM, ObvioHealth brings deep regulatory expertise across global markets. Designed to meet the evolving requirements of the FDA, EMA, FSANZ, and other national authorities, the ObvioGo platform enables faster, more compliant study execution—reducing delays and strengthening submission readiness.
RegASK, our sister venture, specializes in global regulatory intelligence and submission strategy. In close collaboration with ObvioHealth, their experts optimize study design for claims substantiation, provide region-specific guidance, and act as your representative for smooth, compliant submissions across the U.S., EU, Asia-Pacific, LATAM, and beyond.
ObvioGo is designed with clinical-grade security at its core—ensuring that every trial is audit-ready and globally compliant. The platform adheres to 21 CFR Part 11, ICH-GCP, and GDPR, and holds ISO 27001, 27017, and 27701 certifications. All activity is logged, time-stamped, and access-controlled to support full data traceability and integrity from start to finish.
With our unified approach to regulatory alignment and security, you gain a partner equipped to support inspection readiness, de-risk global submissions, and protect sensitive data—every step of the way.
