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.
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.