Partnering from Strategy to Approval

CATO SMS, formed by the merger of CATO Research and SMS-oncology, is a team that will tackle your toughest challenges with confidence and precision. With more than 30 years of global experience, their team is optimized for small and emerging biopharma sponsors like you. Their specialists deliver innovative regulatory consulting solutions to guide you through the most complex regulatory challenges. Their expert teams effectively design and execute clinical trials — from strategy to approval — in complex indications and modalities across a variety of therapeutic areas, with a proven center of excellence in oncology.

Their combination of regulatory, therapeutic, and operational expertise enables them to meet your challenges and seize opportunities that arise before or during study conduct. Whether you need experts in medical affairs, regulatory, clinical pharmacology, or clinical trial management, they can help you meet your goals.

CATO SMS nurtures a high-performance culture in which they provide continuous training and put emphasis on personal and organizational development and opportunities, anchored by a commitment to high quality and personalized customer service. They consider effective, frequent, and open communication as a key component to developing strategies to meet your needs and goals. They provide lean project management to accomplish operational excellence in terms of timelines, quality, and costs. Their motivating culture is represented by their industry leading retention rate that clearly distinguishes CATO SMS.


CATO SMS experts deliver specialized product development services and solutions, designing and executing studies in complex indications and modalities. Their extensive experience in clinical research and strong regulatory consulting team – including former EMA/FDA staff and regulatory experts from pharma and biotech industries - enables them to deliver innovative strategies and consulting insights as you navigate the approval process. With offices and operational teams across North America, Europe, and the Middle East, CATO SMS has experience conducting trials in more than 25 countries.

  • You can count on their expertise to guide your team through complex regulatory requirements; we deliver over 750 regulatory submissions a year. Over 30 years of global experience ensures effective and efficient IND and CTA filings as well as meetings with the FDA, EMA, and country-specific governing authorities.
  • With in-depth expertise and hands-on experience, they meet your challenges, anticipate obstacles, and seize opportunities that arise before or during clinical trial study conduct.

Clinical Trial Operations

Over 30 years of global experience enables them to effectively design and execute studies and meet the needs of small and emerging biopharma sponsors by guiding them from strategy to approval in complex indications and modalities across a variety of therapeutic areas. Globally, CATO SMS successfully conducted over 750 clinical trials ranging from Phase I to IV in numerous indications and patient populations, with oncology representing the majority. Together, these studies enrolled over 60,000 patients worldwide at over 5,500 sites. They have contributed to the successful development of more than 50 marketed products, representing an impressive 10% of all drugs approved by the FDA and EMA in recent years. As your partner from strategy to approval, they provide clinical trial services all the way from design, setup, and full conduct to closure of Phase I to IV studies.

CATO SMS takes pride in building long-term relationships in which their clients can rely on their expertise and proactive, responsive, and pragmatic approach. They offer a flexible and tailor-made approach to the specific needs of every project, either as a full-service solution or by providing the stand-alone services to their clients in clinical trial operations, regulatory consulting, clinical pharmacology and biometrics.

Clinical Trials Innovation Programme

Clinical Trials Innovation Programme is an invitation-only, premium event bringing together a mix of clinical research professionals and service providers in one stimulating environment.

Join us face to face to learn from the best in the drug development industry and have an opportunity to learn from their experiences. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2022 will feature tailored sessions presented by the leading experts from across the globe.

We are bringing together the best in the industry to help you learn and grow, and accelerate your drug development journey. The experts will include thought leaders and visionaries from Danish Medicines Agency, Bayer Pharmaceuticals, AstraZeneca, The Janssen Pharmaceutical Companies of Johnson & Johnson, Travere Therapeutics, Biogen, Vifor Pharma, Medical Products Agency and much more.

Register with us to learn more!