Leverage the full power of Real-World Evidence to Optimize Development and Commercialization
With digitalization and an abundance of new data sources, drug development is entering a new era with regulators and payers looking to incorporate real-world data to inform decision-making. We generate evidence that complements traditional randomized clinical trials, accelerates submissions, expands indications and supports health-economic decision-making. Cytel focuses on using sophisticated statistical, decision modeling and data science techniques to generate evidence that regulators and payers will trust.
Real-World Evidence - Supporting Smarter Clinical Development
Whether you are a smaller organization seeking to optimize your programs, or a larger organization developing an RWE strategy to support a regulatory submission, we can help. Our team can leverage real-world data to:
- Establish external control arms for deeper insights or limiting sample sizes in control arm
- Inform better endpoint selection and improve population targeting
- Predict enrolment with greater accuracy
- Conduct meta-analysis of defining equivalence and non-inferiority margins or relative effect sizes
- Share evidence across RCTs and between RCTs and RWE to make better use of available sample size throughout the development pathway (e.g. extrapolation from adult to pediatric population).
Real-World Evidence – Comparative Effectiveness Research to Support Commercialization
Harnessing real-world data, we can robustly demonstrate effectiveness beyond randomized controlled trials, while informing reimbursement, pricing, and Health Technology Assessment discussions.
Our researchers will help you with the strategy, design and execution of:
- Pragmatic trials
- Comparative Effectiveness Research approaches
- Cost of Illness studies
- Cost-effectiveness and cost-benefit analyses
- Prescription cost analysis
- Budget Impact Analysis
- Reimbursement applications
Right Question, Right Data, Right Time
Our innovative mindset, exceptional people, credibility with regulators, and technology know-how uniquely equip us to resolve the toughest real-world evidence (RWE) generation problems.
We can help you determine and deploy the research questions, data sources and analytical methods required to realize RWE’s full potential while meeting the robust scientific, safety and ethical standards demanded by regulators, payers and patients.