Regulatory, Data Privacy & Security
The parent company of ObvioHealth, SPRIM, has a 20 year history in the global clinical trial industry. This enables us to propose designs and protocols that will meet the regulatory requirements of US and other international regulatory agencies.
Our team of regulatory, security and technical professionals are continuously monitoring regulatory changes, global cyber threats and our defense systems to proactively manage risk and anticipate required mitigations.
Our sister venture, RegASK, is specialized in regulatory intelligence and compliance and, when requested, works hand in hand with the ObvioHealth team to optimize study design for claims substantiation. We can provide country-specific expertise and serve as your representative for communication with local regulatory authorities for any and all submissions to the FDA, EMA, NMPA, FSSAI, FSANZ and other country regulatory bodies.
ObvioHealth is committed to keeping our customers’ and participants’ data and information secure and protected from authorized use. Our clinical trial system has been developed to meet the design, quality, and security controls and requirements of the pharmaceutical industry. The team ensures compliance across the organization through a mix of regulatory programs, certifications and audits.
Our platform is 21 CFR Part 11 compliant and its use for clinical studies adheres to all regulatory requirements and guidelines, including ICH-GCP, GDPR and ISO 27001, 27017, 27701. The system is set up in a way that also allows for external UAT quality control.