Overview

• 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.