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.

CEC Solutions

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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In addition to these services, CEC offers high-quality evaluation, adjudication, and validation of electrocardiographic and electrogram review through DCRI’s Arrhythmia Core Laboratory. Our experienced adjudicators—comprised of HRS board-certified faculty of electrophysiologists—collaborate with other trial support units helping to further set us apart.

CEC has experience in adjudication across numerous therapeutic areas, including cardiovascular studies, respiratory medicine, infectious diseases, gastrointestinal and liver disease, kidney disease, and pediatrics.

ExperienceCounts

Research Highlights

Accuracy and quality

The EUCLID trial incorporated multiple aspects of clinical event surveillance and adjudication with over 11,000 triggers completed.

Process Efficiency

For a recent global, phase III, double-blind, placebo-controlled study, the CEC team was brought in to adjudicate eight events at study end. Only seven weeks passed between the contract signature and the end-of-study deliverable. The average CEC startup process takes three months.

Innovation

Cardiovascular adverse events in the drug-development program of bupropion for smoking cessation: A systematic retrospective adjudication effort.

Safety Surveillance Group

The Safety Surveillance team ensures comprehensive ascertainment and evaluation of safety information by coordinating the development and implementation of the SAE process for DCRI trials. They develop projects specific safety management plans, and are responsible for SAE management and safety medical monitoring activities across trials.

Services include:

  • Full service of trial safety databases or pass-through service, wherein the sponsor holds the trial safety database
  • Receiving and processing site-reported events of interest, pregnancy, UADEs via eCRF, etc.
  • Reviewing and processing negatively adjudicated events (NAE), including further medial review to determine whether the NAE represents a potential serious adverse reaction
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95+ trials closed  Nearly 40 active trials  165,000+ events processed

Leadership

Renato Lopes, MD, PhD
Co-Director, Clinical Events Classification,
Co-Director, ICE-SS,
Professor of Medicine, Cardiology

Schuyler Jones, MD
Co-Director, Clinical Events Classification,
Associate Professor of Medicine, Cardiology

Karen AlexanderKaren Alexander, MD
Director, Safety Surveillance, Co-Director, ICE-SS

Matt Wilson, RN
Director of Operations
Clinical Events Classification-Safety Surveillance

Linda Lillis, MS
Associate Director
Clinical Events Classification-Safety Surveillance