Real-World Data and Real-World Evidence
Real-World Data and Real-World Evidence in Regulatory Decision Making and Generating real-world insights.
AstaLynx provides a tailored approach for use of RWD/RWE for our client requirements with a strategy which can fit for the purpose. We have a team of experts from different disciplines like epidemiology, clinical, medical affairs, commercialization, regulatory and statistics who can help our clients RWE project needs. Key sources of RWD are Electronic Health Records (HER), claims data, prescription data, patient registries, patient advocacy groups and social media.
The passage of the 21st Century Cures Act, there is increasing interest in the use of Real-World data (RWD) and Real-world evidence (RWE) due to their paramount role in supporting drug development and regulatory decision making. It is used frequently in scientific research, drug development, clinical studies, regulatory approvals and market access.
RWE is the clinical evidence about the usage and potential benefits, or risks of a product derived from an analysis of RWD. RWE complements clinical and post-marketing data to provide full range of benefit-risk assessment of a product and adds value to informed decision-making for developing new clinical trials or post-marketing studies.
AstaLynx has the capabilities needed to generate holistic safety profiles for your products. We incorporate a variety of data sources, including RWD, in our analysis. We enable our clients to make the right strategic decisions for their organizations by providing them with the necessary insights and product benchmarks. Our team of researchers and programmers come together to construct a profile consisting of deliverables such as Benefit-Risk Analysis, Comparative Studies, and Signal Reports, to name a few. These deliverables come together to shape a safety profile that can guide enterprise level strategy including commercial and regulatory decision making.
Our RWD/RWE services provides fit for purpose data for different stages of drug development and post-marketing arena, including:
- Generating Evidence Regarding Safety and Effectiveness
- Supporting FDA’s Regulatory Decisions of Effectiveness
- Study optimization- identifying unmet medical need, target population, study design and patient recruitment.
- Pharmacovigilance- observational and non-interventional studies, benefit-risk assessment, signal detection.
- Systematic and targeted literature reviews
- Enhance product commercialization, market access, pricing, and reimbursement.
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