eBook|13 Nov 2025

How 4 pharma giants cut submission prep time by up to 50%

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Four pharmaceutical giants completed R-based regulatory submissions 25-50% faster than traditional methods, transforming clinical reporting. The FDA and EMA now collaborate with sponsors on open-source methods, removing adoption barriers. Universities train graduates in R and Python, pressuring organizations reliant on proprietary tools.

This e-book explores strategies from Roche, GSK, Johnson & Johnson, and Novo Nordisk, including:

· Validated infrastructure for GXP compliance and innovation
· Adoption roadmaps from foundation to deployment
· Risk-based validation frameworks for regulatory compliance

Read the e-book to see how open-source clinical reporting transforms drug development.

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