WHITEPAPER
Regulatory environments for trusted research of RWE data
Empowering pharma and biotech to achieve FDA and EMA compliance with Lifebit’s Trusted Regulatory Environment (TRE).
Achieving Regulatory-Grade Compliance for Real-World Evidence Research
As Real-World Evidence (RWE) becomes mandatory in drug approvals and post-market surveillance, organisations face increasing pressure from regulators like the FDA, EMA, and MHRA.
This whitepaper explains how Lifebit’s Trusted Regulatory Environment (TRE) enables research teams to operate with full compliance to global standards, without centralising or moving sensitive data.
Download the whitepaper to:
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Understand evolving FDA and EMA RWE regulatory frameworks
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Learn how to meet compliance with 21 CFR Part 11, GxP, HIPAA, GDPR, and ALCOA+
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Discover how Lifebit’s federated architecture ensures privacy, traceability, and reproducibility
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Explore automated validation, audit readiness, and inspection-grade transparency
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See how leading pharma companies achieve faster regulatory submissions with reduced compliance risk