Patient safety redefined. Digitised, personalised and optimised.
Patient safety redefined. Digitised, personalised and optimised.
Case Study

Complex REMS management

ETASU REMS – tools to mitigate risk associated with product use. These tools are used to facilitate the requirements approved for product X with a REMS.


Product X required complex system functionality and documentation prior to dispensing for patient use. Prescribers were required to enroll themselves, passively enroll patients, counsel, attest to educational elements, educate patients about associated risk and how to manage use. The pharmacy executes against an extensive set of business rules defined to mitigate associated concerns prior to dispensing to end user. This program required the education of both the patient and a caregiver with the documentation of counseling efforts for all. The inclusion of pediatrics post launch of initial indication required a well-planned review of current processes with the goal of patient safety for pediatrics in mind. This review ushered in a novel approach with measured results for how to include this tender group of patients suffering with a debilitating quality of life.

REMS users icon


8+ years of successfully mitigation of associated risk. Two successful regulatory inspections and 8 successfully approved modifications to the REMS processes. FDA gave a nod in a publication to the success of elements of the REMS ability to mitigate risk associated with this product.


Experienced resource with complex system implementation and negotiations with FDA for novel patient safety approaches. Proven track record with regulatory agency across multiple programs.

Strong relationship built with the Agency for consideration of innovative approaches to risk management.

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