Abstract

Drugs evaluation has been undergoing a transformational shift from the classical sequence of randomized control trials (RCT) and Real-World (RW) studies towards a more agile process capitalizing better and faster from retrospective data. The purpose of this work is to propose a regulatory-grade, data-integrative, real-world-value-based and disease-centric approach to accelerate and de-risk drugs development and launch. This approach relies on disease and care modeling on the pre-competitive space and federated data sourcing.

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