Preguntas frecuentes sobre ObvioHealth

Sponsors can access their projects through the sponsor portal of our clinical trial management system (CTMS). Our CTMS maintains and manages the planning, performing, and reporting functions, along with tracking project deadlines and milestones.

The ObvioHealth platform has its own proprietary, validated EDC system.

ObvioHealth performs automatic data cleaning, auto-edit checks, and advanced query resolutions as the data is entered, enabling us to more quickly advance to analytical review.

The typical time for an ObvioHealth data lock is about 30 days. In some cases and because of our technology, we have been able to reach database lock in as little as 2 weeks.

ObvioHealth has implemented technical and administrative controls which meet ISO standards to address data continuity, including data classification, source data control, data backup and recovery, high availability/disaster recovery, and archival policies. These practices ensure that study data is continuously backed up throughout the study.

The ObvioHealth platform includes a proprietary EDC system. Any time a data point is entered into the system, it is fully auditable. The audit trail is fully compliant with ICH GCP standards and is downloadable.

Our cloud-based EDC system manages and cleans data in real-time and resolves queries, includes a complete clinical trial management system (CTMS), and an electronic trial master file (eTMF). The sponsor can get direct access to the eTMF during and after the study.

Sponsors have access to the study dashboard through a secure webpage which enables them to view all activities and requested analytics in real-time with capabilities to download, print, and review information offline.

Our backend portal allows us to track all the participant information: number of enrolled, completed number, number of patients withdrawn, etc. Sponsors can access our backend portal for real-time information any time that they want to. They can export the questionnaires, and all data is readily accessible for accurate analysis.

The ObvioHealth platform has been developed to be consistent with the design, quality, and security controls associated with the regulatory requirements of HIPAA, GDPR, 21 C.F.R. Part 11, ISO 27001, 27017, and 27701. ObvioHealth received certification in ISO/IEC 27001:2013, ISO/IEC 27701:2019, ISO/IEC 27017:2015, and HIPAA in May 2021.

ObvioHealth has significant experience conducting studies that are compliant with global regulatory requirements. The ObvioHealth platform is 21 C.F.R. Part 11 compliant, and its use for clinical studies or research study management is compliant with all regulatory requirements and guidelines, including ICH-GCP. We have begun external audit and preparation for ISO 27001, 27017, 27701 certifications.

ObvioHealth offers oversight and management of all required regulatory submissions for projects within and outside of the U.S. We work with local IRB’s and the ministries of health to obtain proper approvals. Our system company has extensive regulatory experience outside of the U.S. and can be engaged as needed.

The FDA has identified the modernization of clinical trials as an agency-wide priority and voiced commitment to creating a regulatory framework supportive of innovative approaches to research. As such, the FDA does not penalize the use of decentralized methodologies during the drug development process so long as all regulatory guidelines are followed.

All patient data is stored in a secure database restricted to only authorized ObvioHealth clinical staff and is encrypted, password-protected, and controlled per the highest encryption and compliance standards.