New platform aims to modernize decades-old clinical research infrastructure with purpose-built AI architecture

CUPERTINO, Calif.: #CTMS--Qtis.ai, an applied artificial intelligence company focused on healthcare, medical research, and aesthetics, today announced the launch of its Clinical Research Division and the commercial deployment of its AI-native Clinical Trial Management System (CTMS), a next-generation platform designed specifically for the AI era.

The company also announced its first CTMS customer, Cardiac Dimensions, Inc. (CDI), a privately held medical device company headquartered in Kirkland, Washington. CDI develops minimally invasive catheter-based technologies for the treatment of heart failure and functional mitral regurgitation (FMR) and operates clinical programs globally.

The announcement marks Qtis’ entry into one of healthcare’s fastest-growing software categories. According to Grand View Research, the global Clinical Trial Management System market was valued at approximately $2.4 billion in 2025 and is projected to reach $7.4 billion by 2033, driven by increasing trial complexity, regulatory requirements, and growing demand for digital clinical infrastructure.

“Clinical research remains one of the most data-intensive industries in the world, yet many of the systems supporting it were architected decades before artificial intelligence became practical,” said Mark Swartz, Chief Executive Officer of Qtis.ai. “Modern clinical trials routinely generate hundreds of thousands, and often millions, of data points across sites, investigators, sponsors, CROs, and regulators. We believe the next generation of clinical research infrastructure must be designed around intelligence from inception rather than attempting to retrofit AI into legacy architectures. That’s why we built our platform from the ground up as AI-native.”

Moving Beyond Legacy Clinical Research Software

While many clinical research systems are adding AI-powered features, most were originally designed as transactional software platforms. As a result, introducing modern AI capabilities often requires additional software layers, integrations, and workflows.

Qtis’ CTMS was designed around a unified architecture powered by the company’s proprietary language model, LORIS, enabling clinical teams to interact with the platform using natural language while maintaining operational controls, auditability, and compliance requirements.

“It is one of the most intuitive CTMS platforms our team has evaluated,” said Hank Hauser, Vice President of Global Clinical Affairs at Cardiac Dimensions.

Swartz added, “Ease of use remains a significant challenge in clinical operations, and user adoption is critical to realizing value from any technology platform. The CDI deployment follows successful pilot validation and represents the first commercial implementation of Qtis' clinical research platform."

Addressing One of AI’s Biggest Challenges in Clinical Research

Artificial intelligence adoption in regulated environments presents unique challenges.

Clinical research systems operating under GxP standards require strict controls around traceability, documentation, validation, change management, and audit readiness.

Many existing platforms were not designed with AI governance in mind, creating complexity when integrating modern AI capabilities into legacy environments.

Qtis’ platform was architected to support GxP-ready deployment from inception, incorporating model governance, version control, audit trails, and human oversight into its core design.

“AI cannot be treated as an add-on in regulated environments,” said Swartz. “It must be designed into the platform from day one if organizations expect to realize the benefits of automation while maintaining compliance.”

Building a Broader Clinical Research Infrastructure Platform

The CTMS launch represents the first component of Qtis’ broader clinical research technology strategy.

The company plans to expand its Clinical Research Division with additional enterprise solutions, including electronic data capture (EDC), document management, and integrated research operations platforms designed to support sponsors, CROs, medical device companies, and research institutions.

As clinical research continues to generate larger volumes of data and operational complexity, Qtis believes AI-native infrastructure will become increasingly important to improving efficiency, scalability, and user adoption across the clinical development lifecycle.

About Qtis.ai

Qtis.ai is an applied artificial intelligence company developing AI-native software platforms for healthcare, medical research, aesthetics, and consumer health. The company specializes in intelligent workflow automation, personalized decision support systems, and enterprise software designed to improve efficiency, engagement, and outcomes across regulated industries.

Fonte: Business Wire