Simulate, Automate, and Execute.
AI For Breakthroughs.
Your trial runs on data. Dot turns it into the predictive power and certainty your teams need. Dot simulates outcomes before site activation, automates workflows, and unifies your data, moving you from trial to treatment faster.
Medidata Plus unlocks full access to the AI-layer and Dot’s most advanced capabilities on our AI-native platform.
The Power of Clinically-Fluent AI™
AI specifically designed to help your studies succeed
AI FROM OTHER PROVIDERS
Most are off-the-shelf solutions, retrofitted for clinical research
Proprietary AI, purpose-built for how clinical trials actually work
Lacks the right context to surface the patterns and signals that impact success
Operates with the context of all your data across your entire study, not just one stage or source
Trained on weak/limited datasets
Trained on the industry’s most comprehensive dataset spanning 42K+ trials and 13M+ patients
Operates within questionable or unclear governance frameworks
Developed under a formal AI validation framework with continuous monitoring and human-in-the-loop workflows
Integration is complex and burdensome
Already embedded across the Medidata platform your trials operate within
MEDIDATA’S CLINICALLY-FLUENT AI
Proprietary AI, purpose-built for how clinical trials actually work
CLOSEOUT & POST-TRIAL
Simplify Closeout. Extend Every Trial’s Value
Dot turns your trial's closing data into insight for what's next.
It reviews outcomes to support go/no-go decisions and benchmarks against external comparators to help win regulator and payer approval, while automating database lock, document filing, query resolution, and final payments.
The result: a faster close, and lessons that carry into your next trial.
STUDY EXECUTION
Execute with Confidence. Accelerate to Database Lock.
By automating data aggregation and standardization across every source, your teams get higher quality data, faster review cycles, and real-time insights that lower risk.
End-to-end data traceability preserves context, and natural-language chat with Dot makes audit reviews painless.
BUILD & START-UP
Automate Your Build. Launch Your Study Faster.
AI-powered study build cuts weeks off your path to startup.
Dot generates edit checks and automates form building and systems configuration, freeing your teams to focus on what matters.
Select the right sites the first time with performance forecasts based on actual site performance.
STUDY DESIGN & PLAN
Simulate Outcomes. Optimize Every Trial Decision.
Design for success from day one.
With virtual twins of every trial, protocol, and patient, you can simulate outcomes and surface risks before they become costly amendments.
Streamline protocol design, forecast budgets and enrollment, and model financial scenarios in minutes.
AI Designed for Study Success
Make Better Decisions
Dot is built for the complexities of modern trials, not retrofitted for them.
It spots anomalies, surfaces trends, and knows what should happen at every step.
Embedded across the trial lifecycle, every stage connects to the next, every team works from the same space, and every decision is informed by the full context of your study.
Everest Group recently named us highest-designated luminary in their clinical AI report. Learn more.
Featured Resource
Medidata Plus, Connecting the Dots.
Connect data, workflows, and AI across the clinical trial lifecycle with Medidata Plus.
Download Fact Sheet
Industry Insights
The State of AI in Clinical Trials:
From Pilot to Practice
Uncover how AI in clinical research is evolving from experimental testing to enterprise-wide adoption that transforms every stage of the trial lifecycle.
Report: Everest Group 2026 Innovation Watch: AI in Clinical Trials
Get exclusive access to Everest Group’s assessment of 18 clinical AI providers to see which companies and capabilities are driving the future of clinical trials.
Blog: How is AI Being Used in Clinical Trials? 5 Key Statistics for 2026
Learn how clinical trial sponsors are seeing new efficiencies from the use of AI across the entire trial experience—from study design to feasibility and site selection.
Blog: Clinical Trial Planning: How AI Is Transforming the Process
Read how clinical trial planning is notably complex—and how AI is transforming the process with insights that can proactively de-risk trials before they begin.
Blog: How Clinical Trials Can Maximize Generative AI Investments
Explore how those who invest now in embedding adaptive, workflow-driven AI can accelerate clinical trial timelines, reduce risk, and deliver stronger outcomes.
FAQ
What is Medidata AI?
Medidata AI is purpose-built for clinical trials, not retrofitted or off the shelf. It is trained on validated data from 38,000 trials, 12 million patients, and 70B data points per year. Embedded throughout a unified platform that spans the full trial lifecycle, Medidata AI connects every stage of your trial, ensuring seamless handoffs and eliminating costly rework that often leads to errors. It doesn't just analyze, it simulates outcomes and recommends best actions, making your trial predictive, not reactive.
What is Dot?
Dot is an AI virtual companion, agent, and trial orchestrator embedded throughout the Medidata Platform. It helps teams simulate outcomes, automate workflows, surface insights, and recommends next best actions.
What is Medidata Plus?
Medidata Plus unlocks the intelligence layer built on our AI-native platform. It connects data and workflows across your entire clinical lifecycle and simplifies enterprise adoption.
Medidata Plus brings together AI-powered capabilities across the Medidata Platform, including:
- AI-enhanced study build in Designer
- Data Connect and Transformation
- Audit Explorer
- AI Data Analytics
- Platform Guide
- and much more
These AI-powered capabilities help study teams move faster from insights to action, intent to outcomes, vision to reality.
Learn More About Medidata Plus
How is Medidata AI different from other clinical AI solutions?
Purpose-built for clinical trials, Medidata AI is trained on validated data from 38,000 trials and 12 million patients. Embedded across a unified architecture, it doesn’t just analyze—it simulates outcomes and recommends next best actions, making your trial predictive, not reactive. Insights is produced in context and applied within a study and across development programs, not reset trial by trial.
How does Medidata AI support trust, governance, and auditability?
Models are developed and validated by scientists, physicians, technologists, and former regulatory leaders. Outputs are explainable and auditable, and applied within controlled workflows designed for regulated research. Medidata applies security and privacy practices to anonymize and protect patient data and support patient safety, without increasing operational or compliance risk.
Learn more about Medidata’s unified approach to trust, security, and transparency.