REMS Consulting Services
BioTrak 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. We have established industry best practices for pretesting, developing, and measuring performance of REMS elements. We have over 16 years of experience fielding surveys and conducting commercial research with key stakeholder groups (patients, prescribers, and dispensers, i.e. pharmacists).