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… Benefit-Risk Preferences Benefit-risk preference studies are … options. Benefit-risk preference studies demonstrate the net benefits of treatments by quantifying the relative … positive net benefit from having access to the treatment. Quantitative estimates of maximum acceptable risk can help …
… Benefit-Risk Assessment Do your product’s benefits outweigh its … of benefit-risk assessment and meet the requirements of regulatory and reimbursement stakeholders worldwide. Our … in the same way in both short and long-term studies or using the same units. By engaging with our team early in the …
… address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the … Conducting feasibility assessments for studies using databases and/or primary data collection Developing … plans to use in regulatory discussions Advising on benefit-risk assessment methods for specific products …
… Causal Inference for Regulatory-Grade RWE Among the hurdles for making your … for estimating the product's safety and/or effectiveness using real-world data (RWD). This most often involves causal … who specialize in applying the target trial emulation framework to tackle these challenges. This approach starts by …
… strike between treatment benefits and risks. MCDA provides quantitative 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 …
… for clinical trials, including: Protocol and statistical analysis plan (SAP) development Sample size calculations … 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 …
… Collaborative Regulatory RWE Research Through our Barcelona based team, we … for the registration of pharmacoepidemiological and regulatory RWE studies. Susana Perez-Gutthann has been …
… populations Health benefit price benchmark (HBPB) ranges, using incremental cost per equal value of life year gained (evLYG) … of small molecule drugs should be set at 75% of the launch net price at 9 years after launch. Similarly, for biologic …
… Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the …
… group. However, some patients in your study will benefit more or less than the average. Who are they and can … for market segmentation - Provide evidence for possible risk-sharing plans for reimbursement Regulatory Approval - … may have promising subgroup effects Methods & Applications Using innovative analytical methods based on structural …