Quality Philosophy in Cromos Pharma is driven by our goal to provide clients with the highest quality services and to exceed their expectations. This commitment is rooted in our corporate values and is essential to our continual growth and success. We maintain the highest quality standards via design and continuous improvement of our Quality Management System, which is maintained in full compliance with international standards and regulatory requirements. All business processes in Cromos Pharma are defined, interconnected and designed in a way that allows us to provide our services by the most efficient means possible.

The Cromos Pharma Quality Management System is designed and implemented at all levels and within all processes to assure the quality of all provided services in all Cromos venues, and enables us to consistently deliver the high quality that our sponsors expect.

Some Key Elements of Cromos Quality Management System:

1. Corporate Policy & Culture

  • Full understanding and acceptance of Company’s mission, strategy, values and Quality policy by all employees
  • Understanding and appreciation by employees of the impact of their everyday performance on the overall quality of our services
  • QMS Policy Document
  • Risk Management System (RMS) Policy Document
  • “Teaching/learning culture” that offers employees continuous development and formal mentoring

  • 2. Quality Assurance

  • Intensive training programs based on personal training plans and with the support of company’s electronic Learning Management System;Internal audit activities covering all key quality processes that continuously bolster improvement of our services via regular analysis of the results of these audits
  • Fully compliant system of SOPs, review and revision policy
  • SOPs augmented by Work Instructions geared to local country venue requirements
  • QA metrics factored into KPIs
  • Site and vendor audit program
  • Study specific/sponsor specific Quality Agreements

  • 3. Quality Control & Project Specific

  • TMF Audits, mid-study, end of study
  • Co-monitoring visits
  • Analysis of client’s satisfaction level via diligent collection of client feedback
  • Client and management oversight via dashboards and frequent project meetings
  • Tracking and reporting of project metrics and analysis of outliers
  • Data-driven, risk-based monitoring
  • Study specific risk management plans

  • 4. Management Oversight

  • Trend analysis of key quality metrics; such as CAPA aging, deviations planned/unplanned; audit report response time
  • Quarterly Quality Review meetings attended by top managementMonthly project status review meetings held for management