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.

For more information, please visit www.svmpharma.com and contact us at enquiry@svmpharma.com

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