ENDPOINT ADJUDICATION

We started our first MACE (Major Adverse Cardiovascular Event) studies back in 2004, two years before the release of FDA (Food and Drugs Administration) guidance on
this topic.

years of experience

experts

adjudicated events

supportive submissions

As per as current guidelines, multi-center studies require :

a central review of source data by independent expert teams

a standardized procedure for management of trial-related events

an adjudication platform to increase efficiency in the review of dossiers

Therapeutic areas

Our expertise expands specifically in late phase trials for a broad range of therapeutic areas.

Thanks to our involvement in a large number of studies centralizing endpoint adjudications and our network of board certified experts in various specialties, we are able to provide reliable and accurate review of events for clinical studies in :

anticoagulants

antiarrhythmic

gene therapies

mab

anti-diabetic agents

And several medical disorders, including :

coronary artery disease

atrial fibrillation

arthritis

type 2 diabetes

ventricular arrhythmia

chronic obstructive pulmonary disease (COPD)

heart failure

peripheral vascular disease

Scientific board

Our team guarantees the respect of current regulations to fit the specificities of your project.

Our board of experts supports you through all deliverables of the projects from elaboration of clinically relevant definitions and reading charter to on-time management of endpoint packages. Relevant supportive elements such as accurate status reports as well as study impact analyses are provided to oversee the project. The team of experts regularly employs new team members and is covering several specialists as :

Cardiologists

Pneumologists

Neurologists

Pharmacologists

Radiologists

Management system

Atrium™ suite dedicated to your project

To adjudicate clinical endpoints, we provide a complete and integrated solution based upon a unique set of advanced technologies : the ATRIUM suite. This platform is specifically designed to build, operate, track, and document clinical trials across all study phases from data collection to final publications.

REAL TIME MANAGEMENT

on-line centralization, analysis, and reporting with multilingual consensus via a secure web portal

REAL TIME DATA

efficient data collection and on-line quality control by the adjudication committee members

DASHBOARD & METRICS

executive summary for the sponsor/ CRO team in real time and on-line to oversee project status

Discover our
ATRIUM™ suite

Our know-how dedicated to your project

We offer 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 operational documentation including adjudication charter
Set-up and maintenance of an adjudication web portal

Coordination between the investigational sites, sponsor, and the adjudication committee

Collection and gathering medical records in the adjudication package
Tracking/ follow up and completeness of the adjudication packages
Management of the consensus adjudication meetings
Data quality control
Long term archiving of the documentation

REQUEST A PROPOSAL

Our highly reactive Customer Relationship Managers team brings you Banook Group’s cardiac safety expertise based on your study protocol and guides you through the regulatory submissions for your clinical trials.

REQUEST A PROPOSAL

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