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… Benefit-Risk Assessment Do your product’s benefits outweigh … about your product’s benefit-risk profile. A Structured Approach Tailored to Your Needs Our teams have the expertise …
… Benefit-Risk Preferences Benefit-risk preference studies are a … relative importance of benefits and risks and a patient’s maximum acceptable risk (MAR). If the actual risk exposure … can help you design effective risk management strategies throughout the product development, regulatory, and …
… safety and effectiveness enables us to align the right approach with your objective. Our consulting experience … the appropriate data collection strategies and data source(s) among alternatives Conducting feasibility assessments for … plans to use in regulatory discussions Advising on benefit-risk assessment methods for specific products …
… Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide variety …
… utility values is a vital part of demonstrating a product’s value. We can help you evaluate your needs for utility … and standard gamble - Capture utility data real-time, as events occur, via mobile technology solutions (e.g., … CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team help you generate the …
… Health Preference Assessment Do you know what your patients value and what … , patient-reported outcomes (PROs) and the patient’s point-of-view are increasingly important factors to … and treatment effectiveness Critical satisfaction measures Risk management strategies Risk tolerance assessments Let our …
… (quality-adjusted time without symptoms or toxicity) is an approach that can help patients evaluate the trade-off between clinical benefit and treatment toxicity to make informed treatment … the Q-TWiST method to quantitatively assess the benefit/risk tradeoff of your new treatment regimen. Healthcare …
… Outcomes Let us help you understand your drug’s potential for personalized medicine. Drug research focuses … group. However, some patients in your study will benefit more or less than the average. Who are they and can … claims - Inform safety studies and reduce risks of adverse events Abandoned Drugs - Rescue, repurpose, or resurrect …
… can be used to gain insights at each stage of your product’s lifecycle. We can help you assess the relevance of a … information that can help you understand and communicate risk tolerance from patients and other stakeholders to inform … MCDA can also help catalog issues that could arise in benefit-risk assessments . Additionally, the decision process …
… mode of administration, etc. and so do your competitor’s products—but, do you know which of those attributes matter … with different sets of benefits and potential adverse events. Treatment attributes are relative based on a person’s … is an example of a discrete choice survey item: Image Our Approach Our scientifically-rigorous approach to DCEs ensures …