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

Medidata, a Dassault Systèmes brand and leading supplier of clinical trial services, announced the launch of Medidata Plus. This clinical artificial intelligence layer reveals the full breadth of AI abilities in the Medidata Platform, giving sponsors access to scalable, outcome-based AI through their worldwide portfolios. Medidata Plus transforms life sciences organizations away from a legacy of disjointed, inefficient point solutions to a unified, end-to-end AI strategy, speeding up the delivery of life-saving therapies to patients.

While 92% of organizations' decision-makers plan to raise AI spending, only 29% of AI-based technology currently meets or exceeds their expectations. Medidata Plus addresses these systemic roadblocks directly, turning unpredictable AI expenses into a streamlined, predictable investment by standardizing the data layer in the entire clinical trial lifecycle.

"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-based intelligence to each step of a clinical trial, from research build to information management to continuing challenges monitoring. Rather than relying on a patchwork of disconnected devices, research teams access a single, unified layer of AI-based capabilities built to speed up execution and surface insights in real time. Significant capabilities made accessible via Medidata Plus include:

• Study Builds Accelerated with AI: Lessens research build timelines from weeks to mere hours through automating EDC and eCOA design, and generating synthetic patient information for consumer testing, dramatically hastening research startup times.
• No-Code Data Transformation: Through improved AI interoperability, Medidata Plus seamlessly ingests, standardizes, and transforms information from clinical and real-world sources to extract insights without writing a single line of code.
• Proactive De-risking: Embedded analytics rapidly flag significant enrollment downtrends or safety signals, lessening mid-cycle pauses and hurrying inspections.
• Companioning Audit Exploration: Agentic AI supports research teams to mine their end-to-end audit history using natural-language queries, altering complex regulatory information 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 administrations, ranging from enterprise biopharma leaders to worldwide CROs, are poised to unlock significant value via Medidata Plus, which offers them a decisive technological edge to implement clinical trials with greater exactness, higher quality, and faster timelines.

The launch of Medidata Plus establishes a future-driven framework for platform developments. As Medidata continues to embed clinically-fluent AI in its ecosystem, research teams from sponsors and CROs gain access to an increasing suite of abilities that deliver value in their trial portfolios.

Backed by an AI infrastructure now 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 new drug approvals in 2025.

According to Towards Healthcare, the Clinical Trial Supplies Market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 5.81 billion in 2026 to approximately USD 12.49 billion by 2035, representing a compound annual growth rate (CAGR) of 8.87% from 2026 to 2035, driven by the significant growth in clinical trial supply as it follows advanced practices and implements efficient approaches. This involves everything from optimizing inventory management to leveraging novel technologies to enhance supply chain effectiveness. Implementing cost-saving measures without losing quality and effectiveness is important to optimizing clinical trial supply and to reducing the cost of the clinical trial supply chain while maintaining quality and efficiency. Effective management of clinical supplies and CTM is critical to the success of a clinical trial. By confirming that the required materials are obtainable when and where they are needed, scientists conduct the trial safely and efficiently, leading to faster approvals and enhanced patient results.

About Medidata

Medidata has been driving smarter management and healthier patients by helping clinical trials via groundbreaking technological novelties for over 25 years. Medidata is a leader in AI-based services in the entire trial lifecycle to speed up clinical breakthroughs, lower patient and site challenges, and bring novel therapies to market rapidly. Supported by one of the largest clinical information repositories in the industry, with more than 38,000 trials and 12 million patients, Medidata's Study, Patient, and Data Experiences are trusted by more than 1 million registered consumers across around 2,300 consumers. A Dassault Systèmes brand, Medidata is headquartered in New York City and is recognized as a leader by Everest Group and IDC.

About Dassault Systèmes

Dassault Systèmes is a catalyst for human progress. Since 1981, the organization has pioneered virtual worlds to enhance real life for customers, patients and citizens. Through the 3DEXPERIENCE platform, AI-driven, science-based virtual twins help 390,000 customers of all sizes, in all industries, collaborate, imagine and create sustainable innovations that drive significant impact.

A recent report by Towards Healthcare highlights that the clinical trial supplies market is growing, as clinical trial supplies offer a wide range of advantages, involving enhanced effectiveness, reduced costs, and access to particular expertise. However, it is significant to choose the right outsourcing partner and confirm that they have the experience and resources required to support the trial. Clinical trial supply is an important component of the drug development process, requiring careful planning, management, and coordination. By following significant solutions and leveraging novel technologies, scientists optimize the clinical trial supply chain and confirm that the trial is conducted efficiently and safely.