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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Mission & strategy > Our strategy > Implementing an optimal quality system

Our strategy

Relying on talented women and men
Constantly enhancing our responsiveness and proximity
Implementing an optimal quality system
Developing partnerships

The Banook Group is committed to providing you with innovative and reliable solutions. This approach helps you optimize your decision-making process and reduce costs, while rigorously adhering to good clinical practices and comply with international regulatory requirements.

 

To this end, we have committed to the following four goals:

 

  • Implement and enforce stable and robust processes,
  • Manage the efficiency of our processes and their impact on customer satisfaction,
  • Build and enhance a culture of continuous improvement,
  • Ensure compliance with both customer and regulatory requirements.

 

At Banook Group, quality is everyone’s responsibility. The management team is fully committed to supporting this philosophy and ensuring that the entire staff understands and lives by it.

 

HOW ?

 

  • A dedicated quality department
    Banook Group’s quality department is composed of a quality compliance manager and a team of internal auditors from different teams and departments in the company. The role of the QA group is to conduct internal audits to guarantee that quality commitments have been implemented, support and encourage consistency in compliance to external and internal standards, help improve processes, and manage corrective actions and preventive actions (CAPA ) to ensure compliance with regulations.

 

  • Quality-centered data processing tools
    We have developed robust tools that can support clinical projects and proactively manage changes occurring during their lifetime. All data required for regulatory submissions are audit trailed in accordance with standard predicate rules. All patient data are secured and archived for 15 years.

FDA-XML file standard compliant

We are certified for formatting and uploading ECG data within the FDA warehouse,

using a specific xml format, at the request and on behalf of sponsors.