Transforms adjudication process, enabling sponsors to meet regulatory requirements using centralized and independent expert clinical event review
DOYLESTOWN, Pa., – Bioclinica®, the world-leading provider of technology-enabled solutions for clinical research, today announces the launch of Bioclinica Clinical Adjudication, a transformational offering in which medical specialists and researchers, backed by advanced technology, lead independent Clinical Event Committee (CEC) review. The new service enables the independent adjudication of clinical events in conformance with regulatory requirements governing clinical trials within all therapeutic areas, including cardiac studies and for Major Adverse Cardiac Events (MACE) committees.
Adjudication committee members located anywhere around the globe are able to access Bioclinica’s web-based system to securely and efficiently review clinical event dossiers. Built-in access control and tracking provides for security, protection and audit trail transparency while giving adjudicators ready access to the required information on every clinical event type.
“Bioclinica’s robust electronic adjudication environment allows clinical study sponsors to successfully modernize from paper-based adjudication to a web-based system for greater efficiency, data integrity, and reduced timelines while breaking down geographic barriers.”
- David Herron, President Medical Imaging & eHealth Solutions, Bioclinica
As a key component of the service, Bioclinica brings in a vast network of medical professionals who specialize in the specific endpoint areas, augmented by Bioclinica’s advanced clinical adjudication software for thorough and efficient review of clinical events. As an alternative to tapping this vast network of medical experts experienced in adjudication, sponsors may use their own recommended adjudicators.
Objective endpoint evaluation and assessment is critical in meeting regulatory agency endpoint review requirements throughout a clinical trial to ensure compliance with protocol criteria. Bioclinica Clinical Adjudication enables sponsors to electronically manage the complete process around safety endpoints ─ from notification of an endpoint at a clinical trial site on through to central review by therapeutic experts ─ for a more efficient, objective, and streamlined process than traditional methods, while delivering added quality and time-saving benefits.
“In collaborating, our technology and medical and scientific experts have completely re-engineered the clinical adjudication process,” Herron said. “By uniting medical and scientific expertise with technology, sponsors are able to leverage automation to virtually process key Events from numerous sources, documented in alignment with the clinical protocol.”
Benefits of Bioclinica Clinical Adjudication include:
- Complete and accurate capture of protocol-defined endpoints;
- Quality supporting documentation for suspected endpoints;
- A standardized means to confirm the endpoint drawing on the medical and scientific expertise of independent experts;
- Accurate and timely review of events;
- Transparency in workflow status;
- Immediate data accessibility via analytics; and
- Integration with EDC systems to minimize data entry.
“Whether replacing manual methods or upgrading from earlier electronic adjudication alternatives, Bioclinica customers can expect to see tangible results and lasting value,” Herron comments. “Real-time access to adjudication results and data reports helps slash time and resources while decreasing errors and costs to complete adjudication. We’re pleased to bring this unique and beneficial service to the industry.”