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… models (cost effectiveness, budget impact) Drug utilization studies Epidemiology of disease Exploratory … studies Outcomes research strategy development Physician and payer research Psychometric evaluations of PRO …
… Identifying a Drug's Safety Profile Antiepileptic drugs in pregnancy, and … 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):234. Transcript: A group of … a growing body of evidence showing that each antiepileptic drug has a unique pregnancy safety profile, and that …
… real-world evidence (RWE) at every stage of your drug or device development journey. Experienced Real-World …
… with regulatory guidelines and expectations in the US and Europe, we can help you develop new COAs and modify existing … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… models (cost effectiveness, budget impact) Drug utilization studies Economic burden of illness studies Global … preferences for treatment options Observational studies Physician and payer research Reimbursement dossiers (i.e., …
… illnesses. Benefit-risk preference studies Consulting on drug development and clinical trial design Database analyses … models (cost effectiveness, budget impact) Drug utilization studies Economic burden of illness studies … studies Outcomes research strategy development Physician and payer research Patient-reported outcomes …
… Medicare Drug Price Negotiation (DPN): Implications for Industry Share … Value & Access RTI Health Solutions Now is the time for drug manufacturers to do everything they can to get ready for … submission in support of their product for Medicare's Drug Price Negotiation (DPN) program. To fully prepare for a …
… milestones across the studies, while meeting deadlines for publications. OUR APPROACH We assembled a core team of …
Literature Reviews and Meta-analyses We conduct literature reviews and meta-analyses using the most rigorous methodologies, so you get reliable and reproducible answers to your research questions. High-quality literature reviews can help you understand: …
… Recent FDA Drug and Device Guidelines for Sharing Pre-Approval … July 17, 2018 Communication of Pre-approval Information by Drug and Device Manufacturers to Payers in the US In the US, … or of the new use Product pricing information Patient utilization projections such as epidemiological data …