Expert Clinical Trial Management for Devices & IVDs
Purpose-built for next-generation devices and IVDs, our innovation-driven model turns breakthrough concepts into market-ready therapies that improve patients’ lives.
Device & IVD Trials: A Different Kind of Rigor
Veranex CRO
Trial Design Studio × Evidence Integration Engine
Our clinical trial management approach unites cross-functional expertise through real-time collaboration, eliminating traditional gaps between study design and market access. This integrated methodology ensures protocols satisfy both regulatory requirements and payer expectations from day one. The result: streamlined clinical trial management that accelerates approval while building the evidence foundation for successful reimbursement.
Co-create in the Studio
Clinical strategists, regulatory scientists, statisticians, usability engineers, and health-economics experts draft a global protocol in a single sprint.
Co-create in the Studio
Aligns FDA, MDR / IVDR, and payer expectations in a single sprint, giving you a globally accepted and effective protocol from day one.

Run the Engine
Every endpoint is aligned with approval and coverage criteria for early payer feedback. Leverage regulator feedback channels or our commercialization team’s payer panels.
Run the Engine
Align every endpoint with the standards regulators use for approval and payers use for reimbursement. Additionally, tap into our commercialization payer panels in 30 + countries, so your data story resonates with both audiences.

Stay Efficient & Adaptive
Use Bayesian and frequentist adaptive designs to trim sample size and timelines while preserving study power and integrity.
Stay Efficient & Adaptive
Adaptive designs, supported by US/EU regulators, let us modify enrollment or endpoints based on interim data, so you reach answers faster with fewer participants and uncompromised statistical rigor.

Proven Domain Mastery in Device & IVD Trial Management
Leading cardiovascular, neurological, IVD, and ophthalmology innovators trust our clinical trial management expertise because we infuse every protocol with deep therapeutic insight and executional excellence.

Cardiovascular
As a recognized leader, we accelerate cardiovascular innovation with integrated expertise from concept through commercialization.
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Neurovascular
Collaboration across disciplines ensures neurovascular devices rapidly navigate from design breakthroughs to regulatory approval.
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In-Vitro Diagnostics
From analytical performance to clinical utility, our teams deliver on diagnostic study requirements, ensuring your assays deliver patient impact.
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Ophthalmology
Cross-functional teams optimize ophthalmic device design, clinical trials, and regulatory strategy, delivering clearer vision to market sooner.
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Full-Service or Functional Study Execution
Our flexible clinical trial management model lets you engage Veranex as either a full-service CRO or a functional service provider, scaling precisely the expertise your study needs without adding unnecessary overhead. In full-service mode, we pair your internal team with a dedicated Veranex project lead who oversees every aspect of execution—from regulatory compliance and site monitoring to data collection and reporting—while the functional mode inserts focused specialists into your existing workflows, enabling agile resource shifts and seamless coverage for any gaps.
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Related Services at Veranex
Trial Design
Trial Design
Optimize study design and sample size so endpoints resonate with regulators and payers alike.

Regulatory Consulting
Regulatory Consulting
Navigate MDR/IVDR and FDA pathways with seasoned specialists who accelerate your path to approval.

Commercialization & Market Access
Commercialization & Market Access
Pair regulatory approval with payer-ready evidence by leveraging reimbursement strategies that synchronize coding, coverage, and pricing.

Human Factors
Human Factors
Minimize use-related hazards and slash recall risk by integrating human factors testing from concept through clinical trials.

Fuse Expertise + Evidence with Veranex Clinical Trial Management
Secure the right data with the right partner. Book a consult and see how Veranex fuses expertise and evidence to accelerate both approval and reimbursement



