Quality Assurance and Regulatory

QUALITY MANAGEMENT & COMPLIANCE

Maintaining the Highest Standards of Quality

Embodying a holistic approach centred around risk management, our quality assurance program uses an ISO 9001 accredited Quality Management System. By aligning our operations with the principles of International Conference of Harmonization -Good Clinical Practice (ICH-GCP) and Good Documentation Practice (GDP), we’re able to maintain the highest standards of quality.

Our compliance extends to major regulatory bodies, including the Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Brazilian Health Regulatory Agency (ANVISA). This broad regulatory compliance forms the foundation of our clinical trial solutions.

DIGITAL INNOVATION

Quality and consistency through real-time monitoring

Our Internal Audit Program is meticulously designed to assess and improve our operational standards. We further strengthen our quality assurance through a comprehensive vendor assurance process, ensuring that all our partners adhere to consistent quality standards. As pioneers in the digital realm, we integrate eSource solutions to streamline data management effectively and enhance the accuracy of our work.

To foster continuous growth and maintain top-tier proficiency, we have developed a robust Learning Management System (LMS), demonstrating our commitment to learning and development. This dedication is also evident in our ‘live in-trial Quality Control’ method, an innovative approach that allows for real-time monitoring and ensures consistent quality throughout the trial duration.

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