Explore everything you need to know about RWE in clinical research, from understanding Real-World Data (RWD) sources to its essential applications in R&D, Market Access, and Regulatory decision-making.
Our FAQs provide a comprehensive overview, covering how RWE informs drug development and supports high-quality healthcare decisions. With Schain Research’s AI-powered insights, companies can leverage RWE to advance drug development, optimize market access strategies, and meet rigorous regulatory standards.
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What are RWE and RWD in clinical research?
RWE is derived from RWD collected in routine clinical settings. It includes sources like electronic health records, patient registries,…
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What are examples of RWD?
RWD includes electronic health records, insurance claims, patient registries, and wearables, all of which offer valuable insights for R&D,…
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How is RWE generated?
Generating RWE involves gathering and analyzing data from multiple real-world sources, such as EHRs, claims databases, and patient registries.…
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What is the difference between RWD and RWE?
RWD refers to raw health data collected from everyday clinical settings, such as electronic health records, claims databases, and…
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How does RWE differ from randomized controlled trials?
Randomized controlled trials (RCTs) measure efficacy in controlled settings, while RWE captures real-world effectiveness. This provides insights for R&D…
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How is RWE used in clinical practice?
RWE supports personalized treatment strategies in clinical settings by showing how therapies perform in specific populations. It enables providers…
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What are the benefits of RWE in healthcare?
RWE offers a holistic view of treatment landscapes, reflecting the diversity of real-world patient populations. It supports personalized care,…
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How is RWE applied in drug development?
RWE helps identify patient subgroups, assess long-term safety, and evaluate cost-effectiveness, providing essential data for R&D, Market Access, and…
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How long has RWE been used in drug development, and how has it affected costs?
RWE has gained importance in drug development over the past 20 years, especially with the growth of digital health…
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What role do regulatory bodies like the FDA, EMA, and others play in RWE?
Regulatory bodies such as the FDA in the U.S., the EMA in Europe, and Health Canada recognize RWE as…
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How will AI impact RWE and RWD?
AI enables faster, more precise data analysis, transforming RWE for R&D, Market Access, and Regulatory purposes. With AI tools,…
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How does Schain Research support RWE generation?
Schain Research specializes in RWE solutions for pharma and biotech, offering insights that support decision-making across drug development, market…
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What is a flexible real-world evidence service?
A flexible RWE service offers expert support for studies, strategy, or submissions without requiring long-term hiring. Schain Research provides…
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Can I outsource real-world evidence studies?
Yes. Schain Research offers outsourcing options through “RWE as a Service,” giving companies access to regulatory-grade RWE expertise for…
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Who provides real-world evidence consulting in Europe?
Schain Research is a leading European RWE consultancy, combining scientific expertise, Nordic data access, and flexible delivery models such…
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What’s the difference between RWE as a Service and traditional RWE consulting?
Traditional consulting often involves fixed project scopes or long onboarding. RWE as a Service offers faster access, flexible staffing,…
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When should pharma teams use external RWE experts?
Pharma teams often seek external RWE support during hiring freezes, capacity bottlenecks, or when a project requires niche regulatory…