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… Pharmacoepidemiology and Risk Management Regulatory Real-World Evidence Research Let … activities. To understand disease distribution, risk factors, treatment patterns and impact, comorbidities, … for consulting advice ; database or registry study; prospective observational research ; a literature review ; or …
… address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the effectiveness of risk minimization measures within a risk management plan Performing regulatory landscape analyses …
… Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and … and surveys of patients, physicians, or caregivers. Prospective observational studies can help you: Understand … of patients, physicians, and caregivers Evaluate risk management programs including REMS and EU-RMPs Depending …
… Benefit-Risk Assessment Do your product’s benefits outweigh its … help you navigate the ever-evolving landscape of benefit-risk assessment and meet the requirements of regulatory and … and improved communication about your product’s benefit-risk profile. A Structured Approach Tailored to Your Needs …
… Psychometric Evaluation Our psychometricians have extensive experience … studies to collect data to support psychometric evaluation (independent from clinical trials) Equivalence … psychometric team will help you determine the appropriate evaluation steps and analyses to maximize the value of both …
… Benefit-Risk Preferences Benefit-risk preference studies are a specific application of … provided with a set of actual treatment options. Benefit-risk preference studies demonstrate the net benefits of …
… experience in the rigorous development and psychometric evaluation of clinical outcome assessment measures for use in …
… Determining Effectiveness of Risk-Minimization Measures Impact of Risk Minimization Measures on the Use of Cilostazol in Europe … Cilostazol's use was restricted to second-line therapy in case lifestyle modifications, including smoking …
… Product Research Our experts have collected and analyzed prospective and retrospective real-world data (RWD) for … outcomes research, patient preference, and economic evaluation, to reimbursement and safety activities. We start …
… identifying appropriate treatment stopping rules, finding publications reporting stratified cost and utility estimates, …