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Luto has experience in producing an array of Risk Management information for clinical trials training packages, and teaching tools for patients and healthcare professionals.

We have worked on projects on an international scale. Our experience enables us to improve and develop a range of print and digital Risk Management information that is not only aesthetically appealing, but by applying simple yet effective readability best practice principles is also comprehensive, engaging and designed to capture the widest possible audience.

The EMA publish lay summaries of Risk Management Plans for all new medicines. Luto have User Tested early versions of these and found that they did not meet the needs of lay people.

Working with you to redesign your RMP lay summaries, we can make them clear and understandable by:

  • Simplifying the language used, broadening accessibility

  • Re-structuring, making documents easier to navigate.

Applying our methods of User Testing will ensure lay people can find and understand the information within these summaries.

Risk Evaluation and Mitigation Strategy (REMS)

REMS is key in ensuring patient safety and meeting regulatory requirements for your product.


Luto can write, design and test your REMS program materials. By applying information design and readability best practice principles; we can create easy to read, clear and engaging materials. We can test the materials with the intended users to ensure the serious risks are understood and users know what action to take to mitigate those risks.

With Luto’s help, you can ensure your REMS is right first time, obtaining FDA approval and reducing the risk of product launch delays.

  • Medication guides

  • Training tools

  • Educational materials

  • Dear Doctor letters

  • Counselling tools

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