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… RWE Studies Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and post-approval strategies, or answer … and its treatment Quantify and characterize product safety Evaluate real-world effectiveness of a health care …
… Drug Safety in Pregnancy Satisfy Regulatory Requirements With Help … from regulatory agencies include studies with prospective data collection and studies that make secondary use of …
… regulatory submissions, epidemiology studies, and drug, vaccine, and medical technology safety and … among alternative approaches Selecting the appropriate data collection strategies and data source(s) among … Conducting epidemiological research related to pregnancy Based on your needs, we provide consulting support …
… settings increases, it is critical to understand how to incorporate real-world evidence (RWE) at every stage … or device development journey. Experienced Real-World Data Analysis for Medical Product Research Our experts have … You can have confidence in our experts to help you develop robust RWE strategies and conduct scientifically rigorous …
… Identifying a Drug's Safety Profile Antiepileptic drugs in pregnancy, and … conducted a cohort study using nationwide Swedish Registry data. The study included over 5,000 women who used …
… Identifying an Appropriate Drug for Comparative Safety Research Antiepileptic Drugs in Pregnancy: Searching for a Reference Drug for Comparative … drugs during pregnancy. It is important to know how safe these meds are. To explore the comparative safety of …
… and prescribers understand the real-world use, value, and safety of your products. Observational studies are also … , biostatisticians , psychometricians , and drug safety leaders, we can help you with: Burden/cost of … forms, informed consent forms, and interview guides) Data collection systems development, verification, and …
… potential risks? More importantly, do you have the right data to credibly demonstrate this to regulators, payers, … Our teams have the expertise essential for developing a robust plan to assess benefits and risks. Once we have helped … post-approval activities. This includes: Understanding how a structured approach can improve your evidence …
… Causal Inference Using Real-World Data: How Pharmacoepidemiology Studies Can Benefit From the Target … Healthcare professionals, policy makers, and patients need robust evidence on the effects of healthcare interventions to … clinical trials and robust information on rare adverse events was lacking. As the availability of real-world data …
… Outline Best Practices for Collecting Patient Experience Data During the COVID-19 Outbreak Share on: April 9, 2020 … drew on current FDA recommendations for patient-focused drug development (PFDD) and other more emergent regulatory … team using the form on this page to learn more about about how we can partner with you in patient experience data …