CONTEXT: A claim that will no doubt be tested – “Regulatory-grade evidence”. What exactly constitutes regulatory-grade RWE? Time will tell as we move into a new era for RWR | The ‘Holy Grail’ of real-world research is the ability to produce ‘regulatory grade RWE i.e., evidence that is robust enough to survive regulatory scrutiny and support regulatory and HTA submissions | US-only data set?
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1. “CHICAGO, Feb. 25, 2021 /PRNewswire/ — EVERSANA™, the pioneer of next-generation commercial services to the global life sciences industry, today unveiled its comprehensive data, technology and services solution to bring the power of real-world data to chronic disease research, evidence generation and patient support.”
2. “Through the ACTICS by EVERSANA technology platform, paired with robust outsourced service capabilities in value and evidence research and patient hub services, EVERSANA’s Chronic Disease Real-World Data (RWD) solution enables life sciences stakeholders to conduct regulatory-grade research studies, generate evidence and provide data-driven insight and proactive support to improve the chronic, comorbid patient experience.”
3. “”The use of RWD to generate regulatory-grade evidence in chronic disease has the potential to speed cures to patients, enhance evidence for treatment, and give a stronger voice to patient experience,” said Brigham Hyde, President, Data & Analytics, EVERSANA.”
4. “The Chronic Disease RWD solution further integrates digital and hub-collected patient experience insights from EVERSANA’s hub and patient services.”
5. “”As we’ve advanced our patient-centric hub and support services, we’ve seen firsthand how chronic disease is marked by often difficult aspects of the patient experience,” said Jim Lang, CEO, EVERSANA.”