Genius eCEA™ – Electronic Clinical Endpoint Adjudication
CEA-adjudicated endpoint outcomes can figure prominently in a number of key clinical trial decision-making processes such as power calculations, periodic safety reviews, sample-size re-estimation and other interim analyses, next stage progress for adaptive design trials, study completion for event-driven trials, and overall results for efficacy and safety analyses.
Genius eCEA™ technology enables implementation of an end-to-end, transparent endpoint workflow, which creates significant cost efficiencies and measurably reduces cycle times by offering a collaborative workspace for all relevant experts to contribute to the endpoint process, by automating the process steps with a flexible electronic workflow, and by integrating all components of the endpoint management and adjudication workflows into a single, seamless system, which is embedded within the Genius eCRF™ platform.
The incorporation of all endpoint-related data capture and workflows into the Genius eCRF-based platform makes the endpoint reporting, endpoint management, and CEA adjudication processes fast, convenient, cohesive, and cost-efficient, with a consistent and high-quality result.
Genius eCEA™ benefits
- Eliminates manual handoffs
- Facilitates paperless document and medical image collection, data integrations, real-time information exchange among adjudicators and electronic dossier compilation and review
- Allows ongoing adjudication with immediate, real-time access to data
- Allows committee members to adjudicate events independently over internet and reach consensus on ongoing basis
- Provides immediate notification of inconsistencies & incomplete data to CEC members
- Achieves significant reductions in overall endpoint cycle times, shortening the time from endpoint report to final adjudication by a third of the total duration typically observed with a paper-based process
- Options to support all of the different CEA adjudication models that are in use
- Provides flexible, easily configurable workflow
- Sends email alert to the adjudicators that they have a new action to take
- Provides full-scale technical infrastructure support, including a 24×7 Help Desk to system users
- Includes a project library, including: online posting of system user manuals, trial protocols, CEC charters, and clinical event/endpoint definitions
- Lowers project costs by eliminating courier and fax charges required to transport paper documents from sites to endpoint coordinating centers
- Reduces, and in some cases eliminates, travel costs, required for regular face-to-face CEC adjudication meetings
- Reliable and secure 21 CFR Part 11 compliant system with complete audit trails