Real-World Evidence for Post-Authorization Activities
Following successful market authorization, real-world evidence moves to the forefront. Being prepared for post-authorization activities will help ensure you make the most out of your asset. Our industry-acclaimed team of pharmacoepidemiologists has extensive experience and fosters collaborative research to help identify and access appropriate data sources. We have conducted numerous post-authorization efficacy and safety studies—including pregnancy and breastfeeding research—to support regulatory decision-making.
Our highly qualified researchers are here to provide you with complete support to help you successfully navigate the regulatory process. We also have comprehensive knowledge of advanced analytical methods and health economics and market access expertise. You can trust our combination of skills to help you utilize existing data sources for new insights and evidence to help you further differentiate your asset throughout the product lifecycle.
We can help you:
- Undertake post-marketing commitments (effectiveness and safety)
- Conduct pragmatic and naturalistic trials to compare new treatment with SOC/comparators
- Conduct adherence/persistence/switching studies with SOC and comparators
- Conduct head-to-head comparative-effectiveness studies
- Evaluate potential label changes and treatment landscape
- Update dossiers and economic models with new/contemporary data
- Establish long-term clinical outcomes
- Establish differentiation in subpopulations
- Establish differentiation vs. generic competitors
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