As per current guidelines, multi-centric studies require:
A central review of source data by independent expert teams (adjudication committees, review board, clinical event/endpoint committee…),
And uniform procedures for handling trial-related events.
Banook/Cardiabase was awarded its first MACE (Major Adverse Cardiovascular Event) adjudication in 2004, one and two years before the EMA and FDA, respectively, finalized their guidance on this topic. Since then, we have been involved in a large number of endpoint adjudication projects for various therapeutic classes, including anticoagulants, antiarrhythmics, gene therapies, mab, anti-diabetic agents and several medical disorders, including coronary artery disease, heart failure, atrial fibrillation, ventricular arrhythmia, peripheral vascular disease, arthritis, and type 2 diabetes.
Our board of experts supports all aspects of the process from development of clinically relevant definitions and charter development to timely field management of endpoint packages and sophisticated status reports as well as study impact analyses.
To adjudicate clinical endpoints the Banook Group offers a complete and integrated solution based upon a unique set of advanced technologies, the Atrium™ Suite. The suite is an innovative platform specifically designed to build, operate, track and document clinical trials across all study phases from Electronic Data Capture (EDC) to final publications.
Features and benefits of the Atrium platform include:
Real time Management, analysis and reporting of centralized data data via a secure web portal,
Real time data access and online voting for the adjudication committee members,
Dashboard, metrics and executive summary views enables the sponsor/CRO teams to view project status in real time.
Banook Group offers a full range of comprehensive and proactive endpoint adjudication processes and technologies solutions including:
Identification, training and coordination of the adjudication committee members,
Management of the operational documentation,
Set-up and maintenance of an adjudication web portal,
Coordination between the investigational sites, sponsor and the adjudication committee,
Tracking/follow up and completeness of the adjudication packages,
Management of the consensus adjudication meetings,