Veranex, a global provider of product development and contract research services, today introduced the industry’s first Innovation CRO (iCRO)—an integrated development and research platform engineered to move medical devices and in-vitro diagnostics (IVDs) from concept to commercial success faster, with tighter budget control and a built-in path to payer adoption.

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Veranex launches Innovation CRO for device and diagnostics.

iCRO: Innovation Without Waste

The Veranex iCRO model is built on four core pillars:

1. Speed & Capital Efficiency – Integrated teams and workflows can cut 3–6 months per development phase and reduce budget variance 18 percent versus transactional (traditional) outsourcing. Flexible partnership tiers—Full Stack, Stage Select, and Strategic Augment—let sponsors deploy only the iCRO services they need while retaining velocity.
2. Evidence Integration from Day One – Product design research, human factors engineering, and reimbursement strategists collaborate upfront in the iCRO model to identify data packages that resonate with regulators, investors, and payers—reducing the likelihood of late-stage pivots commonly encountered today.
3. Device & IVD Specific Depth – Over 1,000 device & IVD programs and 2,500 clinical trials completed by a team of 800+ experts across North America, Europe, and APAC. Veranex brings deep expertise in cardiovascular, neurovascular, ophthalmology, in-vitro diagnostics and more.
4. Regulatory & Market Access Alignment – 96 percent approval rate and proven market access pathways in 30+ countries, guided by in-house health economics analysts and payer panels.

"Speed and capital efficiency are no longer competitive advantages—they are survival mandates," said Patrick Donnelly, Chief Executive Officer, Veranex. "Our Innovation CRO answers that mandate with excellence and rigor, integrating every critical discipline—design, engineering, preclinical, clinical, regulatory, quality, manufacturing, market access—into one accountable team that delivers validated evidence at every step."

Meeting Today’s Market Demands

The iCRO model addresses evolving industry challenges where venture investment and access to cheap capital in MedTech have dropped significantly from recent highs. Constrained teams face industry consolidation and internal capability gaps, while evolving EU MDR/IVDR and FDA requirements extend market clearance timelines. At the same time, artificial intelligence features are racing into next-generation devices, raising both regulatory scrutiny and evidence demands. In this complex landscape, today's innovators need more than traditional vendors. They need strategic partners who can deliver integrated solutions with speed and certainty.

"Whether you’re a seed-stage innovator or a global strategic, our iCRO partnerships enable clients to focus scarce capital on innovation while we derisk execution across multiple geographies," said Ryan Roberts, Chief Commercial Officer, Veranex. "We provide access to cross-functional expertise precisely where and when it's needed, accelerating progress toward critical milestones."

About Veranex

Veranex is a global, fully integrated Innovation CRO dedicated to accelerating MedTech innovation from early concept through commercialization. Headquartered in Raleigh, N.C., and powered by more than 800 specialists worldwide, Veranex combines design & engineering, preclinical, clinical, regulatory, manufacturing, and market access expertise to deliver clarity, confidence, and speed—turning vision into velocity for device and diagnostics innovators.

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Introducing the world's first Innovation CRO (iCRO)—delivering safer, smarter, faster MedTech development in today's challenging capital markets. From concept to commercialization, we're redefining how medical device innovation gets done.