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Quality Management

At Astrum, our Quality Management System (QMS) is more than a framework. It is a testament to our unwavering commitment to excellence within the pharmaceutical, biotechnology, and clinical research sectors. When it comes to ethical practices and ensuring participants’ safety, Astrum aims to be a beacon for the industry. We rigorously adhere to regulatory requirements, ensuring that every project we undertake maintains the highest standard of quality.

This commitment extends to our operational methods, where we employ state-of-the-art technologies and innovative strategies to maintain operational excellence, always operating in accordance with regulatory requirements.

We ensure our team not only possesses the relevant skills, but are also up-to-date with the latest industry advancements. Our thoughtfully crafted Standard Operating Procedures (SOPs) reflect this expertise, designed to meet the best practices and regulatory requirements.

Our quality standards equally extend to our partnerships, where we ensure our vendors and subcontractors align with our high standards. This comprehensive approach is crucial in maintaining the consistency and reliability of our services.

Furthermore, our proactive approach to audits and quality reviews demonstrates our commitment to not just maintaining but constantly enhancing our quality standards. This systematic method enables us to effectively manage risks, ensuring the highest level of project success and partner and client satisfaction.

How can we help you?

Contact our expert team to discover how Astrum can bring value to your clinical development projects.

 

Other services

  • Clinical Development & Scientific Advice

    Ranging from first in human to post-marketing, Astrum’s clinical development expertise spans the entire development cycle, offering support every step of the way

  • Clinical Operations

    Your trial will receive full support and expertise across Feasibility, Study 
Start-up, Site Management, Clinical Monitoring, and Trial Coordination 
and Administration

  • Regulatory Affairs

    We provide comprehensive regulatory services to help you navigate the 
ever-changing regulatory landscape and ensure efficient delivery of your 
clinical studies