The global market for pharmaceuticals continues to grow as manufacturers move to expand their market strategy and product pipeline to new markets and therapeutic areas. Increasing globalization has fueled changes in the regulatory environment, including increased data requirements at the various stages of product development, validation, approval, and production. Additionally, numerous recalls and regulatory settlements have left policymakers and consumers questioning the safety of medical products and the manufacturers that bring them to market.

As a result, Real World Evidence (RWE) in the form of late-phase clinical studies (Phases IIIb and IV) constitutes a rapidly expanding segment of the clinical research environment and regulation of the biopharmaceutical marketplace. Regulatory agencies around the world are requiring additional data about the long-term safety and efficacy of new products when they are used by broader patient populations in real-world settings. Healthcare providers — and those who pay for healthcare — are demanding that new therapies provide better outcomes or greater value than existing standards of care and are increasingly looking for real-world clinical evidence to support these claims.

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