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Real world data strategy and programs of research: A roadmap for late phase success

Related topics: Pharmaceutical/Biotech, Medical Affairs & Stakeholder Engagement, Real-World Evidence & Late-Phase Research, Global (non-specific)

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  • In the context of spending constraints, and aggressive go-tomarket timelines, the generation of compelling real world evidence of the effectiveness, safety and value of a novel therapy or medical device has never been more challenging.
  • Peri- and post-approval evidence requirements, which vary markedly across countries, are increasingly demanding both in terms of data needs, and total research and development cost.
  • To navigate this reality, a comprehensive evidence development plan that systematically identifies gaps, and organises and prioritises a synergistic program of scientifically robust real world studies in support of market access is of paramount importance.
  • An evidence development plan that is based on a thoughtful and stepwise multi-national data and feasibility assessment strategy, will result in the right evidence to support a product’s value proposition while optimising cost savings and timeline efficiencies.
  • Data strategy and feasibility assessment case studies alongside a roadmap for cost and timeline savings in the context of technology enabled programs of research will be presented.

Krista A. Payne
Vice President, Late Phase Studies, Real World Evidence
Evidera, Canada

Dimitra Lambrelli
Research Evidence, Real World Evidence
Evidera, UK

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This is the presenters’ personal opinion and does not necessarily represent true facts, the official views or policy of their organisation, nor the views of Evidence Life Science.

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