April 2017

Event Participation 2017

Banook Group will attend the following exhibitions. Let’s meet there!
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February 2017

Cardiabase by Banook Group opens subsidiary in Montreal, Canada

Group strengthens its presence in North American market, aiming for 30% growth in…
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May 2016

Webinar : ECG Assessment in Early Phase 1 Studies: How to get it right for possible TQT waiver?

Reserve your webinar seat now (limited number of places)   Click here :…
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March 2015

Banook Group - New branding announcement

Cardiabase/Banook Central Imaging becomes Banook Group - New branding announcement.
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March 2014

Webinar: Imaging anti-cancer treatment response at a preclinical and clinical stage

Use of imaging in oncology clinical trials is mainly based on morphological evaluation…
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Webinar

Webinars

Webinar : ECG Assessment in Early Phase 1 Studies: How to get it right for possible TQT waiver?

 

Duration: 1 hour

 

Presented by:
Pierre Maison-Blanche - MD – Senior Advisor – Banook Group
Thierry Duvauchelle – MD - Clinical Pharmacologist – Phaster 1
Mathieu Felices - Pharmacometrician & Biostatistician - Phinc

Agenda:
Session #1
10 years from “ICH E14” to “ICH E14 Q&A (R3)”


The purpose of the presentation is first to assess the implementation IQT (intensive QT) study as an alternative to the TQT studies; then to assay sensitivity in IQT Studies.

Session #2
Implementation of “ICHE14 Q&A (R3)”


Taking into account that the priority is to generate guidance on concentration-response modelling, the exposure response as an alternative to IUT analysis will be assessed during this presentation as well as the usage of adequate modeling and definitions for a negative drug.

Can pharmaceutical companies afford not to have Adjudication Committees?

 

Duration:  1 hour.

 

Presented by:

Christian Funck-Brentano, Banook Scientific Advisor – MD, PhD, F.ES.C – Professor of Medicine and Pharmacology; Director of the Clinical Investigation Center at Pitié-Salpêtrière University Hospital, Paris, FR.

 

Hans-Christoph Diener, Banook Scientific Advisor – MD, PhD, FAHA, FAAN – Professor of Neurology and Chairman of the Department of Neurology at the University of Essen, GR.

Introduction:
In this discussion we highlight that the establishment of an Endpoint Adjudication Committees is crucial in most randomized multicenter trials. In such trials, the quality of documentation of primary and secondary endpoints needs to be guaranteed according to pre-established definitions. Several studies have shown that up to 25 % of events reported by investigators in multicenter trials are reclassified by an adjudication committee.

 

Agenda:

  • What are the main reasons behind having Endpoint Adjudication Committees in clinical trials?
  • How to organize an adjudication committee?
  • When plan an adjudication committee?
  • Business cases

 

Cardiac Safety in Clinical Trials: Early QT assessment and novel Arrhythmia Monitoring Techniques

 

Can « early QT assessment » replace the TQT Study?

A discussion on circumstances under which carefully conducted early phase 1 trials can exclude a QTc effect at the level of regulatory concern, and the role of concentration exposure modelling.
During this presentation the results of the IQ-QT initiative Study will be presented, together with the Cardiac Safety Research Consortium white paper.

Novel Arrhythmia Monitoring Techniques for Clinical Trials :

The purpose of the presentation is to assess the role and utility of novel arrhythmia monitoring technologies for clinical trials. The lecture will cover the different technologies including implanted devices, potential use in clinical trials for safety assessment and Atrial Fibrillation detection in the general population.

 

Duration:  1 hour.

 

Presenters: 

Pierre Maison-Blanche - MD - Chief Medical Officer - Banook Group
Pr. Etienne Aliot – MD, PhD – Chief Scientific Officer - Banook Group

Imaging anti-cancer treatment response at a preclinical and clinical stage

 

Use of imaging in oncology clinical trials is mainly based on morphological evaluation of tumor size and determination of response using the RECIST criteria. In this talk, we will explore the use of more advanced imaging techniques as tools to advance precision medicine.

 

Duration:  1 hour.

 

Presenters: 

Xavier Tizon, PhD., Head of the imaging lab, Oncodesign 

Gérard Nitenberg, Ph.D., CEO Europe & Scientific Advisor, Banook Central Imaging.