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Outcome-Driven Solutions for Medtech Challenges

Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.

Purpose-built solutions. Proven results. User & Patient-centered innovation.

 

Purpose-Built for Breakthroughs

Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity.  Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.  

We are the Innovation CRO.

Legacy of excellence. Proven execution. Patient impact accelerated.

 

Transform Clinical Trial Project Management into Launch Momentum

Our medical device specialists orchestrate every study milestone faster and smarter, so breakthrough devices reach patients sooner.

Medical Device Expertise Matters in Clinical Trials

Unlike drug trials, device studies must juggle hardware iterations, surgeon learning curves, UDI traceability and ISO 14155 as well as FDA IDE and EU MDR/IVDR rules. Generalist CRO playbooks miss these nuances:

  • Regulatory precision. FDA warning letters cite “inadequate monitoring of device investigations” year after year.
  • Hands‑on OR know‑how. A misplaced training curve can stall first‑patient‑in and inflate burn rate for cash sensitive start-ups.
  • Supply‑chain accountability. Chain‑of‑custody lapses jeopardize safety and data integrity; full traceability is mandatory for high‑value implants.

Partnering with a project management team built for medical devices protects timelines, budgets and patient safety simultaneously.

 

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Clinical Trial Project Management Strategies That De‑Risk Your Trial

See how Veranex turns clinical trial project management into a competitive edge.


Each tab reveals a device-specific tactic—refined in our Trial Design Studio, tested in live studies, and proven to keep timelines tight, risks low, and launch momentum high. Explore how we translate strategy into action for innovators just like you.

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Strategic Trial Design & Execution Optimization

From Day 1, we treat your study as if it were our own. At concise weekly touch‑points we share milestone progress, flag emerging risks, present mitigation options, and review performance readouts—so small‑ and mid‑size innovators stay perfectly aligned with the plan and progress being made. If a screen‑fail spike, shipment delay, or patient issue appears, we surface it immediately—together with the fix—keeping your leadership and board updates smooth and launch momentum intact.

Sponsors say the level of transparency and collaboration with Veranex feels less like a vendor relationship and more like adding a seasoned project manager to their in‑house team.

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Proactive Timeline, Risk & Budget Management—An Extension of Your Team

From Day 1, we treat your study as if it were our own. At concise weekly touch‑points we share milestone progress, flag emerging risks, present mitigation options, and review performance readouts—so small‑ and mid‑size innovators stay perfectly aligned with the plan and progress being made. If a screen‑fail spike, shipment delay, or patient issue appears, we surface it immediately—together with the fix—keeping your leadership and board updates smooth and launch momentum intact.

Sponsors say the level of transparency and collaboration with Veranex feels less like a vendor relationship and more like adding a seasoned project manager to their in‑house team. 

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Device Logistics & Accountability Oversight

Field CRAs verify UDI labels, temperature controls and unused‑device reconciliation at every visit, ensuring a 100 % audit‑ready chain‑of‑custody and eliminating supply‑chain surprises that can halt enrollment. Track every lot from factory to implant and store proof of condition in the eTMF—so no implant is ever “lost in transit” and recall readiness is built‑in.

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Vendor &  3rd‑Party Coordination

From contracts to SLAs and communications labs, imaging, eCOA providers and more thereby reducing the administrative burden from your team and preventing the hand‑off delays that can derail trials. Your Veranex project management lead can serve as the primary point of contact for 3rd parties involved thus keeping them aligned, performing and resolving issues before they touch your timeline or budget.

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Continuous Inspection Readiness – Fuel for Launch Momentum

Mock FDA/NB audits, eTMF QC sweeps and ongoing site coaching keep documents indexed and deviations resolved, so regulator visits never slow your critical‑path timeline. CAPA tracking and last‑minute “binder scramble” elimination mean every site can open its doors tomorrow and pass—with zero critical findings recorded to date—protecting both approval speed and brand reputation.

Meet the Team

Device‑Focused Leaders, Aligned with Your Launch

Decades of operational, regulatory, and data-ops expertise powering next-generation device breakthroughs

Daisy_Lee

Daisy Lee

Clinical Study Manager
veronique-treil

Véronique Treil, PhD

Director, Quality and Regulatory Affairs
ada-Saltarski

Ada Saltarski, MSc.

Sr Clinical Study Manager

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Device-experienced CRAs spot and resolve issues in real time, safeguarding data integrity and patient safety.

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Solution-oriented data management engineered for medical-device trials, delivering clean, audit-ready datasets at speed.

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Biostatistics & Statistical Programming 

EU MDR Consulting 

Device-savvy statisticians convert trial data into regulator-ready evidence using adaptive designs and robust analytical methods.

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Clinical Trial Design 

Clinical Trial Design 

End-to-end study optimization sharpens endpoints, surfaces insights, and maximizes regulatory and evidence impact.

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Ready to Start Your Clinical Trial?

Discover how device‑centric project management can compress timelines, control risk and speed your path to first‑in‑human and study success.