Medidata Launches Medidata Plus, AI-Native Platform to Scale Clinical Trial Portfolios

Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions, today announced the launch of Medidata Plus, a clinical artificial intelligence layer that unlocks the full breadth of AI capabilities across the Medidata Platform. The announcement was made on July 23, 2026, giving sponsors access to scalable, outcome-driven AI throughout their global portfolios.

Medidata Plus shifts the life sciences industry away from a legacy of disjointed, inefficient point solutions to a unified, end-to-end AI strategy, accelerating the delivery of life-saving therapies to patients. While 92% of industry decision-makers plan to increase AI investment, only 29% say AI currently meets or exceeds their expectations. Medidata Plus addresses these systemic roadblocks directly, turning unpredictable AI costs into a streamlined, predictable investment by standardizing the data layer across the entire clinical trial lifecycle.

Medidata Plus brings AI-driven intelligence to every stage of a clinical trial, from study build to data management to ongoing risk monitoring. Key capabilities made accessible through Medidata Plus include:

• Study Builds Accelerated with AI: Reduces study build timelines from weeks to mere hours by automating EDC and eCOA design, and generating synthetic patient data for user acceptance testing.
• No-Code Data Transformation: Seamlessly ingests, standardizes, and transforms data from clinical and real-world sources to extract insights without writing a single line of code.
• Proactive De-risking: Embedded analytics instantly flag critical enrollment downtrends or safety signals, reducing mid-cycle pauses and accelerating inspections.
• Companioning Audit Exploration: Agentic AI supports study teams to mine their end-to-end audit history using natural-language queries, transforming complex regulatory data into actionable insights in minutes.

"We've listened to our customers and they're clear that AI can transform clinical trials, but not as an army of agents from disparate sources trained in disparate ways," said the CEO of Medidata. "Medidata Plus is a drop-in AI strategy for clinical research that upskills teams, automates workflows, and surfaces insights at a pace that's redefining what teams thought was possible. We are in conversations with dozens of customers about making this shift and what we're hearing tells us the industry has been waiting for exactly this."

Backed by an AI infrastructure recently recognized with the highest "Luminary" rating in Everest Group's AI Innovation Watch Report, Medidata's AI continues to set the standard in clinical trials, having supported 80% of FDA novel drug approvals in 2025.

Medidata has placed AI at the center of its clinical trial strategy, embedding AI across the clinical trial workflow, from protocol design and site selection to patient enrollment, data review and risk detection. The company introduced Dot, its AI orchestrator, as a tool designed to connect patient experience, study experience and data experience inside the clinical trial workflow. Medidata described a "virtual twin" approach to clinical trials, simulating budget scenarios, site payments, enrollment curves and country or regional site strategies before a study begins. Medidata Plus serves as the platform layer for this strategy, a subscription-based service that brings together Medidata's AI capabilities, data integration tools and operational support across clinical trial planning, execution and analysis. The company also highlighted Clinical Data Studio, a data quality management solution that allows clinical trial data to be reviewed in real time.

The company said more than 7,600 clinical trials are currently being operated on its platform. Over the past 27 years, Medidata has supported more than 38,000 clinical trials and more than 12 million patients worldwide, and it processes about 70 billion data points annually. Medidata is headquartered in New York City and its platform is trusted by more than 1 million registered users across approximately 2,300 customers.