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, or a communication plan to health care providers. Through our PharmaTrak program, we have established industry best practices for pretesting, developing, and measuring performance of these 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). PharmaTrak can help you fulfill commitments to survey and report on understanding of risks and measure medication compliance by:
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Developing survey protocols and questionnaires for key stakeholders
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Pretesting REMS elements with stakeholder groups and performing survey validation studies
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Implementing and fielding survey methodologies at agreed upon intervals
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Reporting on assessment findings
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Delivering real-time results reporting through PharmaTrak Viewer
Insight and Expertise in Protocol Design and Survey Fielding for REMS Assessments
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Novel and thorough validation process ensures proper survey performance, data capture, and comprehension by key stakeholders.
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Secure web hosting and bilingual telephone support
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Proprietary web portal provides easy access for all stakeholder respondents. Visit www.treatmentsurvey.com to see the access portal for all REMS assessment surveys.
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Real-time web stats reporting through PharmaTrak Viewer
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Proven, efficient and reliable fielding methodologies for achieving a representative stakeholder sample
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Access to large physician ailment panels as needed