You’re in this industry because you want to make a difference in the health and lives of patients.

You put everything you have into your product, so you’ll accept only the best from the teams you choose. When the stakes are this high, you need a high-performance partner for your clinical trial management needs.
You need CATO SMS.

Who We Are

Tackle Your Toughest Challenges With Confidence

With more than 30 years of global experience, our expert teams provide regulatory consulting services and solutions and effectively design and execute studies — from strategy to approval — in complex indications and modalities across a variety of therapeutic areas with a commitment to making trials digital.

Learn more about our services

Effective Strategies – Innovative Solutions

Our proven center of excellence in oncology gives you insights and results from startup to completion. Patients are relying on you to discover lifesaving treatments; you can rely on us to deliver therapeutic, clinical operations, and organizational insights for all oncology projects.

Learn more about our therapeutic expertise

Partner With the Experts

Our combination of regulatory, therapeutic, and operational expertise enables us to meet your challenges and seize opportunities that arise before or during study conduct. With more than 30 years of global experience, our team is optimized for small and emerging biopharma sponsors like you.

We provide valuable insight, high-quality deliverables, and unmatched client service, giving you expert guidance to identify the specialized solutions you need. From regulatory consulting solutions to pharmaceutical product development, we have the experts to guide you every step of the way. We know how important your product is to you and to the patients who are waiting.

CATO SMS acquires Nuventra to expand drug development offering into clinical pharmacology

The addition of Nuventra’s team of highly experienced consultants expands CATO SMS’ portfolio of solutions in strategic consulting, pharmacokinetics/pharmacodynamics (PK/PD), pharmacometrics (population PK), and biosimulation services.

Learn more about our new clinical pharmacology offering and how it can help support your drug development efforts.

 

Mind the Gap: The Importance of Gap Analysis in Securing Regulatory Approval

Objective gap analysis is an important step towards achieving greater success with new drug applications (NDAs) and biologic licensing applications (BLAs). Catching missing or inadequate items early in the process can mean the difference between success and failure.

We partnered with Informa Pharma Intelligence to bring you critical insights in navigating regulatory requirements and expectations to avoid unnecessary delays and get your products to market faster. Read Now

Roadmap to Marketing Authorisation in Europe: Taking all the right turns

Approval of your Marketing Authorisation Application (MAA) is the final hurdle to pharmaceutical product launch in Europe. Adequate and timely navigation of this roadmap is essential to achieve a successful review by the EMA. Taking the appropriate steps and implementing them into your development process may begin earlier than you expect.

Learn how to ensure compliance, avoid late surprises, and maximise the value of your program at all phases of development.