Risk Evaluation and Mitigation Strategy

Ensure the specific safety needs of your therapy are met

Our risk evaluation and mitigation strategy (REMS) programs include centralized regulatory and compliance services for the collection and maintenance of all data elements that will be reported back to the FDA. Services include:

  • Designing and maintaining registries of prescribers, pharmacies, distributors and patients
  • Assessments to determine if patients are receiving and understanding medication guides

Monitoring and evaluation tools

All materials can be passed through the hub and provided to the prescriber, pharmacy, infusion center and patient and tracked through our validated monitoring and evaluation tools.

Meeting the communication requirements of REMS is imperative and challenging. We can help you educate, inform and raise awareness of a drug’s risk by disseminating information to healthcare providers and professional societies as well as educating prescribers on key safety measures and serious risks to assure safe use.

If your therapy is dispensed through a specialty or retail pharmacy, we help ensure that each dispense includes your medical guide detailing the seriousness of the drug-specific risks.

The most extensive component of a REMS program is the elements to assure safe use (ETASU), which are intended to reduce a specific serious risk listed in the labeling of the drug. We support these requirements through prescriber training, reporting on evidence of safe use conditions, patient monitoring and registry enrollment.

Maintaining a central database of patients who are prescribed your therapy is a critical role to tracking the safe use of your drug as well as quickly identifying any problems that may arise. We can build and maintain this database so that you can submit your findings to the FDA regularly.

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Learn how we can create opportunities for you with our REMS program.

972.350.9600
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