Ebook for Clinical Data & Platform Leaders
Learn how pharma companies are building validated, flexible platforms to support both regulatory submissions and modern analytics.
This guide walks you through the building blocks of an effective SCE, what works, what doesn't, and how to build or modernize a system that supports both compliance and innovation.
Tips on how to approach architecture, vendor evaluation, and team setup for a scalable, compliant SCE.
See how companies like Roche, Novo Nordisk, and others built modular, scalable environments.
Best practices for meeting GxP, 21 CFR Part 11, and EU Annex 11 without slowing down your teams.
What to consider when making decisions about architecture, deployment models, validation, and cross-functional teams.
Pharma leaders have already navigated the challenges of building modern, validated Statistical Computing Environments (SCEs). Learn from their journeys and avoid common pitfalls.
Understand the core components that define a strong, compliant, and scalable Statistical Computing Environment. From environment setup to data management, discover the building blocks that support both regulatory submissions and exploratory data science.
Explore the key decisions behind every successful SCE rollout. Get practical guidance on deployment models, technology stacks, validation plans, and vendor selection whether you’re working with a small team or a global organization.
Get real-world examples from top pharma companies. See how they tackled compliance, scalability, and performance while modernizing their environments for both regulatory and research use cases.
Explore how open-source technology – particularly R and Shiny is transforming clinical trials and the broader pharmaceutical industry.