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The Digital Statistical Computing Environment (SCE) Playbook for Clinical Development

Navigating Change: 10 Highlights from the FDA's Draft Guidance for Decentralized Trials

As innovation in clinical development continues to accelerate and decentralized trial (DCT) models become more widely adopted, the volume of clinical trial data from a variety of sources continues to proliferate, creating both opportunities and challenges for life sciences organizations. While more advanced trial modalities such as DCT make trials more accessible and relieves patient burden, the volume and variety of study data collected adds to the complexity of managing clinical data workflows throughout the trial lifecycle.

This ebook highlights how sponsors can leverage an integrated Statistical Computing Environment (SCE) to get in front of these new clinical development challenges to streamline the production of submission deliverables while increasing programming and analysis efficiencies. Insights include:

  • Historical approaches to statistical computing and factors driving the need for high-performance computing environments within life sciences organizations
  • SCE adoption trends and key considerations for taking a modern approach to statistical computing
  • Benefits of leveraging an integrated SCE to streamline digital trials

ENGAGE 2024- October 10-11, Boston.