Clinical Endpoint Adjudication

An increased interest of regulatory authorities, has evolved, in holding sponsors accountable for the demonstration of proper safety management and classification of simple and composite morbidity and mortality endpoints as either primary or secondary endpoints.  Establishing appropriate criteria as either a key efficacy outcome or as a reinforcement to a test article’s safety profile requires an experienced team throughout the entire development process.

Averion’s seasoned Clinical Endpoint Committee (CEC) as experienced Endpoint Coordinating Center (ECC) manages the full  adjudication process from development of standard and clinically reasonable definitions to charter development, timely endpoint package field management  and sophisticated status report and impact analysis.    Averion’s  CECs and ECC has developed processes to ensure that events will be devoid of reviewer bias and/or cultural differences.   

Averion has more than 12 years experience in administering CECs and Coordinating the endpoint review process.  Recent experience includes endpoint adjudication for cardiovascular disease, medical device and diabetes trials.

Endpoint Adjudication Services:

• Identification and definition of clinical endpoints
• Development of protocol language
• Trained and industry experienced committee members
• Develop endpoint charter and associated SOPs
• Prepare weekly/monthly status reports
• Perform relevant study specific statistical analysis:
  • Event Gap analysis
  • Projection analysis
  • Concordance analysis   
• Collate CEC adjudication events
• Meeting coordination/facilitation
  • Orientation meeting
  • Endpoint review meetings/teleconferences/webinars
• Dossier preparation (adverse events, laboratory data, CRF data, source documents)
• Translation coordination
• Provide CEC recommendations to Sponsors
• Maintain CEC files
• Reconciliation across the clinical, safety and endpoint databases so that no event is lost
• Audit central files

Averion has identified key study considerations based on years of experience administering CECs for endpoint adjudication.   
Click here to download Averion's list of considerations and consequences.   Or, Email Us Now.