REVIEWS

EAC Services

Endpoint Adjudication Committee (EAC)

Independent Clinical Endpoint Adjudication 

Enhanced Data Integrity

Centralized and independent oversight reduces variability in endpoint assessments, enhancing data consistency and reliability.  Our well-defined adjudication workflow minimizes delays, facilitating timely endpoint assessment without compromising quality. 

Improved Independence

Whether the trial requires just one independent medical expert or multiple EAC members, endpoint adjudication must be independent of the sponsor per U.S. FDA and EU EMA guidelines. Ensure independence when you separate clinical trial oversight from trial execution and conduct. 

Unmatched Expertise

Leverage Advarra’s worldwide network of over 1,500 medical experts, biostatisticians, and other clinical professionals. Our EACs are comprised of world-leading experts with the technical prowess to evaluate the most challenging endpoints and the experience to understand the various comorbidities, and confounding variables present in complex clinical trials. 

Optimized Compliance

Save time and resources with truly integrated review services. While the review committees are separate, Advarra coordinates all the institutional review board (IRB), institutional biosafety committee (IBC), data monitoring committee (DMC), and EAC reviews to reduce delays and ensure consistency.  

Comprehensive EAC Services 

Setup and Charter/Plan Development

  • Independent committee formation administered by Advarra  
  • Collaborative development of EAC plan/charter and member selection with sponsor/CRO
  • Recruitment, contracting, and staffing of qualified medical experts  
  • Secure data exchange management  

Endpoint Analysis and Committee Meetings

  • Establishment of secure data transfer  
  • Real-time or scheduled committee review of endpoints per EAC plan  
  • Active collaboration with sponsor/CRO on safety or design issues  
  • Rapid production of EAC recommendations and report to sponsor/CRO  
  • On-demand meeting services

Comprehensive EAC Services 

Setup and Charter/Plan Development

  • Independent committee formation administered by Advarra  
  • Collaborative development of EAC plan/charter and member selection with a sponsor or contract research organization (CRO)  
  • Recruitment and staffing of qualified medical experts  
  • Secure data exchange management  

Endpoint Analysis and Committee Meetings

  • Establishment of secure data transfer  
  • Real-time or scheduled committee review of endpoints per EAC/clinical event committee (CEC) plan  
  • Active collaboration with sponsor/CRO on safety or design issues  
  • Rapid production of EAC/CEC recommendations and report to sponsor/CRO  
  • On-demand meeting services

Featured Content

Technology-enabled Reviews 

Improve compliance and reduce administrative burden with the most integrated reviews solutions in the industry. All of our review services are supported by best-in-class technology platforms, which provide clients with real-time information on review timelines and deliverables. Advarra’s platform for safety oversight administration and reporting (SOAR) provides connectivity and role-based transparency for all parties involved in an Advarra-administered EAC.

Compatible with any electronic data capture (EDC) or similar clinical records system and configurable to handle sophisticated adjudication determinations with parallel, sequential, and other complex determination workflow types. 

Advarra’s reviews technologies integrate easily into a sponsor’s electronic trial master file (eTMF) platforms and site systems via API. 

Frequently Asked Questions

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