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Executive Summary

Artificial intelligence (AI) has crossed a threshold in clinical development. Since 2024, AI has moved decisively from pilot projects and point experiments into embedded use across trial planning, execution, and oversight. Sponsors are no longer asking whether AI works, but where it delivers repeatable value and how to scale it responsibly across portfolios.

Collage of various headlines with mentions of AI across the pharmaceutical industry.

In 2026, AI is actively being used to:

  • Reduce protocol amendments by benchmarking eligibility criteria and endpoints against historically successful trials
  • Compress feasibility timelines by weeks through automated cross‑trial and cross‑market comparisons
  • Improve enrollment rates by identifying viable patient cohorts earlier and aligning site selection with real‑world performance data
  • Support more consistent regulatory and operational decision‑making through curated, auditable data foundations

What has changed most is not the technology itself, but how it is operationalized. Sponsors that are seeing sustained impact share three characteristics: trusted data with transparent provenance, AI embedded directly into trial workflows, and governance designed to enable scale rather than restrict innovation.

This paper focuses on how AI is being used today: what makes it work in practice, and what sponsors should do next.

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FAQ

AI is reshaping clinical trials by accelerating processes such as patient recruitment, site selection, and protocol optimization. It enables predictive and prescriptive analytics, helping sponsors forecast timelines, identify risks early, and design more efficient, patient-centric trials. These capabilities reduce costs and improve success rates.

AI-driven systems significantly reduce drug discovery timelines — from four to five years to as little as six to eight months — by analyzing vast datasets and predicting molecular interactions. AI also enables drug repurposing, personalized therapies, and operational excellence in clinical trials. These improvements enhance efficiency, lower costs, and improve patient outcomes.

Emerging trends include the integration of digital twins, edge AI, and quantum AI into clinical workflows. Digital twins simulate patient profiles to optimize treatment strategies, while edge AI enables real-time monitoring via wearables for decentralized trials. Quantum AI is being piloted for complex tasks like protein folding and toxicology prediction. These innovations promise faster, more personalized, and secure drug development.

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