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Medidata Launches Medidata Plus, an AI-Native Foundation Built to Scale Clinical Portfolios

Medidata Launches Medidata Plus, an AI-Native Foundation Built to Scale Clinical Portfolios
Medidata Launches Medidata Plus, an AI-Native Foundation Built to Scale Clinical Portfolios

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

SINGAPORE โ€“ Medidata, a Dassault Systรจmes brand and leading provider of clinical trial solutions, today 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.

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.

โ€œStitching together point solutions isn’t a strategy โ€” it’s a liability. Drug development’s next leap will come when AI is consistent, connected, and portfolio-wide,โ€ said Dr. Nimita Limaye, Research VP, Life Sciences R&D Strategy and Technology, IDC. โ€œMedidata 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.โ€

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.

โ€œWe’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,โ€ said Anthony Costello, CEO, Medidata. โ€œMedidata 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.โ€

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 โ€œLuminaryโ€ rating in Everest Groupโ€™s AI Innovation Watch Report, Medidataโ€™s AI continues to set the standard in clinical trials, having supported 80% of FDA novel drug approvals in 2025. To learn more about how Medidata Plus delivers an easy, fast, and AI-powered clinical research experience, visit here.

About Medidata

Medidata has been powering smarter treatments and healthier people by supporting clinical trials through groundbreaking technological innovations for over 25 years. Medidata is a leader in AI-powered solutions across the entire trial lifecycle to accelerate clinical breakthroughs, reduce patient and site burden, and bring new therapies to market faster. Supported by one of the largest clinical datasets in the industry of more than 38,000 trials and 12 million patients, Medidataโ€™s Study, Patient, and Data Experiences are trusted by more than 1 million registered users across approximately 2,300 customers. A Dassault Systรจmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and is recognized as a leader by Everest Group and IDC. Discover more at medidata.com. Listen to our latest podcast, from Dreamers to Disruptors, and follow us at @medidata-solutions on LinkedIn.

About Dassault Systรจmes

Dassault Systรจmes is a catalyst for human progress. Since 1981, the company has pioneered virtual worlds to improve real life for consumers, patients and citizens. Through the 3DEXPERIENCE platform, AI-powered, science-based virtual twins help 390,000 customers of all sizes, in all industries, collaborate, imagine and create sustainable innovations that drive meaningful impact. For more information, visit: 3ds.com

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For interviews and questions, please contact Medidata PR
Medidata.PR@3ds.com

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Medidata.AR@3ds.com

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