Clinical Endpoint Adjudication

Maintaining independence and consistency by ensuring adherence to protocol-defined endpoint events is a vital aspect of many clinical studies. The Baim Institute is consistently innovating our process and has set the industry gold standard in clinical endpoint event adjudication.

Applying Consistent Definitions

The Baim Institute employs a team of MD and RN specialists who are experienced in the interrogation of clinical study datasets to identify and adjudicate study endpoint events across a broad range of therapeutic areas.

This centralized identification of study endpoint events results in a higher quality clinical study and greater assurance of the consistency of reported study endpoints. This team of clinical reviewers averages more than 30 years of critical care experience across a variety of therapeutic areas and has an average of eight years of event adjudication experience.

To further validate the accuracy of these events, the Baim Institute’s medical team prepares clinical narrative summaries for submission to its Clinical Events Committee (CEC) for final adjudication. The Baim Institute’s CEC meets frequently and membership includes leading academic-based physicians in various areas of clinical specialty across multiple therapeutic areas. The Baim Institute’s unique CEC model provides rapid identification and confirmation of endpoint events to assure an expedited closing of the clinical database.

  • Since 1999, we have processed and submitted more than 50,000 cases for CEC adjudication.
  • The Baim Institute conceived and led the Academic Research Consortium (ARC) efforts to implement consensus definitions for stent thrombosis in clinical trials of drug eluting stents (DES) under the leadership of Donald Cutlip, M.D.
  • Also under the direction of Dr. Cutlip, the Baim Institute conceived and led Valve Academic Research Consortium (VARC) efforts to implement consensus definitions for clinical studies of percutaneous heart valves.
  • We also provided the adjudication and analysis for the FDA special panel meeting on stent thrombosis and DES. The Baim Institute supplements its CEC services with the eClinicalOS web-based adjudication system. We work closely with our sponsors to ensure that the system specifications are adequate for the nuanced nature of each study. Each study database is designed by the Baim Institute’s internal adjudication experts. The interface and features provide mechanisms that ensure a timely turnaround of service and the ability to adjudicate cases in-stream, which results in a scalable, efficient adjudication process.Our CEC group provides the following services:
  • Generation of CEC Charters
  • Selection, and vetting through conflict of interest, the required quorum of CEC physicians
  • Narration (and coding) of endpoint events, including report-quality narratives
  • Identification of potential endpoint events
  • Adjudication of potential events across multiple therapeutic areas by a panel of medical experts
  • Online adjudication database platform, including results dataset transfers
  • Entry of results into sponsor’s clinical database