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Causal Inference for Regulatory-Grade RWE Among the hurdles for making your healthcare interventions available to patients is being able to meet regulatory requirements for estimating the product's safety and/or effectiveness using real-world data (RWD). …
… compared to other types of dementia. Antipsychotics are a second-line treatment for this condition, but an increased …
… strategy prior to your gene or cell therapy or tissue-engineered product obtaining regulatory approval. If your … Therapies (RMAT) or the EMA’s Advanced Therapy Medicinal Products (ATMP) designations, getting a jump on this planning …
… understand the real-world use, value, and safety of your products. Observational studies are also increasingly … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… set into as many exposure groups as you want to study, second, censoring those clones when they deviate from their …
Clinical Trials With broad therapeutic experience across all phases of clinical development, we can provide a complete set of statistical services for clinical trials, including: Protocol and statistical analysis plan (SAP) development Sample size …
… the market, economic evaluations are going to play a key role in pricing, access, and reimbursement decisions. …
… health care economic and scientific information about your products ahead of FDA approval can help improve patient … are planning, forecasting, and budgeting for new pipeline products helps make new medications and devices available for …
… companies showcased their capabilities, underscoring the role of RWE in understanding long-term treatment effects, …
… health technology assessments, or HTAs, of pharmaceutical products have existed for a while, HTA organizations have in … in the selection process – that will impact evidence generation needs and submission planning. Learn more about …