REMS Consulting Services
PharmaTrak™ offers a range of FDA Risk Evaluation and Mitigation Strategies (REMS) custom consulting and fulfillment services, including pretesting and ongoing assessments of REMS tools and elements. REMS elements may include a medication guide, a patient package insert, a communication plan to health care providers, or a stakeholder registration and verification process. Through our PharmaTrak program, we have established industry best practices for pretesting, developing, and measuring performance of REMS elements. We have over a decade of experience fielding surveys and conducting commercial research with key stakeholder groups (patients, prescribers, and dispensers, i.e. pharmacists).