A Real-World Evidence Program to Meet Your Regulatory and Market Access Needs
Implementing successful real-world evidence strategies start here. This is the time to understand where your product fits in the commercial landscape and begin to develop your value proposition. We can help you identify potential gaps in your evidence and create a plan to address them—saving you time and costly re-work down the road. Our cross-functional teams have the expertise you can rely on for objective research and advice to plan an efficient and cost-effective real-world evidence program to meet your regulatory and market access needs.
We can help you:
- Identify standard of care
- Evaluate appropriate trial designs, endpoints, comparators, populations
- Literature review: Evaluate epidemiology and natural history
- Literature review: Evaluate burden of illness (economic, humanistic, societal) and unmet needs
- Develop HEOR strategy and tactical plan
- Collect and evaluate patient experience data
- Develop COA strategy and tactical plan
- Conduct risk/benefit tradeoff study modeling
- Assess patient preference
- Develop an early economic model (identify gaps in model inputs)
- Describe disease and therapeutic area landscape
- Understand the Payer landscape
- Conduct safety and effectiveness research in countries where the medication is approved to support the new drug application/market authorization
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