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CATO SMS is a full-service clinical and regulatory contract research organization (CRO), specializing in complex areas such as (immuno-)oncology, advanced therapeutics and orphan diseases. CATO SMS has a center of excellence solely dedicated to oncology.  

CATO SMS brings a powerful blend of capabilities focused on supporting small and mid-sized biotech (representing approximately 70% of our clients), top-tier pharmaceutical companies and investigator groups with their innovative research. We offer regulatory consulting and drug development affairs in addition to clinical trial management services, leveraging the experience and know-how in all disciplines to the full benefit of your company. Our proactive approach in the highly competitive and evolving trial landscape gives you a head start and allows you to be on top of the data, make informed decisions, mitigate risks and seize opportunities that arise before or during trial conduct. 

We employ over 320 dedicated professionals with offices and operations in over 25 countries around the globe including the United States (US), Canada, Europe, Israel and South-Africa. Our European headquarters is strategically located close to the European Medicines Agency (EMA) in Amsterdam, the Netherlands, and our US offices in close proximity from the Food and Drug Administration (FDA) in Washington. Our dedicated professionals include a high percentage of full-time physicians and doctoral-level scientists. The close and direct involvement of our senior management team drives efficient trial conduct to the highest quality and standards. 

Full range of services: 

  • Consultancy - drug development strategies 

  • Medical writing  

  • Clinical operations & project management 

  • Regulatory affairs 

  • Medical affairs 

  • Pharmacovigilance 

  • Biometrics & statistics 

  • Insights & analytics 


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