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Quality Management

Astranova Research places a strong emphasis on Quality Management, which is integral to all our activities. Our Quality Management System ensures a harmonized approach to delivering and maintaining quality and compliance, covering all aspects of our operations.

Quality Culture:

Quality Risk Management

Processes & System

Oversight

Issue Management

Knowledge Management

Document Management

Audit & Inspection Readiness

We collaborate with you on your projects to ensure compliance with the Guideline for ICH Good Clinical Practice (GCP) and local regulatory requirements, safeguarding participants and ensuring data integrity. Our quality management approach is implemented throughout all project phases, from initial client contact to study closure and reporting.
Astranova Research offers global coverage of Clinical Research Compliance and Training, as well as Quality Assurance, with personnel in Australia, China, East Asia, India, and the USA.
Our approach includes:

  • A risk management approach to projects and activities
  • Audits, such as investigator site, database, systems, and vendors (e.g., GMP, GLP)
  • Inspection readiness
  • Training and knowledge management
  • Comprehensive standard operating procedures
  • Process reviews
  • Trending from audits and quality management activities to enhance processes and training (continuous improvement)
  • Monitoring oversight (quality visits, document reviews)
  • Vendor selection, management, and oversight
  • Regulatory support

Astranova Research provides quality assurance from design to delivery, ensuring that your projects meet the highest standards of quality and compliance.