01.002 RWE GS Aug 2022 E 17-08-2022

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 and CRO, with a focus in Real World Evidence (RWE) for pharmaceutical and biotechnology companies. SVMPharma delivers clinical trials within UK and Europe.


DISTILL is a new EDC launched by SVMPharma. As a CRO discover the benefits of DISTILL as part of your service offering and take back control of your clinical trials. DISTILL allows you to develop and manage every aspect of your trials from start to finish. Move away from the restrictions and costs associated with legacy systems.

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