Genius eCEA

Electronic Clinical Endpoint Adjudication

Genius eCEA

Electronic Clinical Endpoint Adjudication

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
Corporate Vision MagazineAward Winner

Exom is proud to announce that Corporate Vision Magazine has awarded us the 2021 Corporate Excellence Award as "Most innovative Full-Service CRO" for our technology-driven approach to clinical trial management.

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