FDA see expanded role for real-world evidence (RWE); Merck KGaA and Pfizer generate RWE for regulatory submission

  • RWE has the potential to both accelerate approval timelines and reduce the costs of drug development
  • RWE studies must uphold established standards of evidence – including standards for Good Clinical Practice (GCP) and 21 CFR Part 11 requirements
  • Concerns around the reliability of real-world data collection and data gaps limit the potential value of RWE studies.
  • To overcome this barrier, companies may need to look beyond current vendors and establish strategic partnerships with new and emerging vendors

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About SVMPharma

SVMPharma is an innovative strategic consultancy, specialising in Real-World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real-World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.

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