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 24x7 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
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