Built on an award-winning AI foundation, Medidata Plus removes traditional barriers, empowering sponsors and CROs to scale intelligence across entire portfolios

Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions, announced the launch of Medidata Plus. This clinical artificial intelligence layer unlocks the full breadth of AI capabilities across the Medidata Platform, 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.

"Stitching together point solutions isn't a strategy — it's a liability. Drug development's next leap will come when AI is consistent, connected, and portfolio-wide," said Dr. Nimita Limaye, Research VP, Life Sciences R&D Strategy and Technology, IDC. "Medidata Plus delivers this with a cohesive AI layer across the entire lifecycle, shifting organizations from sporadic AI adoption to a continuous, portfolio-wide strategy that drives real clinical outcomes." 

Medidata Plus brings AI-driven intelligence to every stage of a clinical trial, from study build to data management to ongoing risk monitoring. Rather than relying on a patchwork of disconnected tools, study teams can access a single, unified layer of AI capabilities built to accelerate execution and surface insights in real time. 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, dramatically accelerating study startup times.
• No-Code Data Transformation: Through enhanced AI interoperability, Medidata Plus 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 Anthony Costello, CEO, 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."

Life sciences organizations, ranging from enterprise biopharma leaders to global CROs, are poised to unlock significant value through Medidata Plus, which provides them with a decisive technological edge to execute clinical trials with greater precision, higher quality, and accelerated timelines. 

The launch of Medidata Plus establishes a future-ready framework for platform advancement. As Medidata continues to embed clinically-fluent AI across its ecosystem, study teams from sponsors and CROs will gain access to an expanding suite of capabilities that deliver value across their trial portfolios.

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.