Clinical Events Classification

Clinical Events Classification

The DCRI Clinical Events Classification group uses innovative strategies, including integrated adjudication and data management processes, so that adjudicated endpoint data are available on time for the Independent Data Monitoring Committee (IDMC), database lock, and other important timelines throughout a trial.

Experience Counts

Our clinical events classification experience includes work on phase II–IV clinical trials in multiple countries and has included 200,000 patients with more than 150,000 events adjudicated.

Comprehensive services for the development of highly efficient events adjudication programs include:

  • Consulting expertise in clinical events adjudication processes, including electronic data capture and paper-based trials
  • Collaboration in protocol development
  • Systematic identification of suspected events
  • Access to an international group of clinical experts with experience in clinical trials and event review/adjudication
  • Preparation and review of event packets
  • Liaising with regulatory agencies
  • Preparing peer-reviewed publications on clinical events adjudication processes and results
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Renato Lopes, MD, PhD
Co-Director, Clinical Events Classification

"Our exceptional faculty and operational teams work together in a close, cohesive way to achieve impressive results for our sponsors."
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By the Numbers

The team processed more than 36,000 adjudications and 8,000 safety events across more than 84 active studies in 2016.

Case Study: EUCLID Trial

This was the largest study of peripheral artery disease completed to date, enrolling more than 13,500 patients at more than 900 sites in 28 countries.

The DCRI CEC and Safety clinical program for EUCLID was a team effort that incorporated multiple aspects of clinical event surveillance and adjudication with over 11,000 triggers completed.

 

CEC has expanded its role beyond the traditional cardiovascular studies and has diversified into emerging areas for adjudication, including respiratory medicine, infectious diseases, gastrointestinal and liver disease, kidney disease, and pediatrics.

 

Leadership

renato-lopesRenato Lopes, MD, PhD
Co-Director, Clinical Events Classification
Professor of Medicine, Cardiology

schuyler-jones-newsSchuyler Jones, MD
Co-Director, Clinical Events Classification