Quality

“Success does not simply happen. How you fare depends not on luck or coincidence. There is a reason for everything.” (Aristotle's law of causation)

Solid and proven quality management is our key to customer satisfaction, successful projects and our ongoing sustainability and growth.

Metronomia’s commitment to high quality in all of our business areas is directly linked to our success in client audits and regulatory inspections, e.g., European Medicines Agency (EMA), Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and United States Food & Drug Administration (FDA).

Our Quality Management System, comprising effective standard operating procedures (SOPs) and regular internal audits, is designed to ensure adherence to international quality standards, best practices and ethical principles. At Metronomia, we foster a climate of continuous monitoring and improvement that is the foundation for delivery of better data.

Quality Management System

  • SOPs available for all services
  • Regular internal audits
  • Constant Audit- and Inspection-readiness
  • Compliance with ICH-GCP (International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice) guidelines, regulatory requirements and industry standards.
  • Audited member of Bundesverband Medizinischer Auftragsinstitute (BVMA, German Federal Association of Contract Research Organisations)
  • Regular sponsor-initiated system or study audits, internal audits and inspections - Successfully passed all client audits and EMA, BfArM and FDA inspections

Quality Management Principles & Key Elements of Metronomia’s Quality Management System

  • Customer focus
  • Continual improvement
  • Quality documents with controlled lifecycles
  • Qualified and trained employees
  • Validated computerized systems
  • Established business continuity processes
  • Comprehensive quality program
  • Quality control & assurance
  • Risk Assessments
  • Contractor qualification
  • Change control
  • Corrective and preventive action (CAPA)

“To achieve the best possible results and customer satisfaction, we push ourselves to maintain high quality through monitoring, implementation of lessons learned, and continuous improvement. We stand for high quality clinical research. Our audits, trainings and regulatory updates show it!”