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.

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.
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.
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.
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.
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.
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.
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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
Clinical Study Manager
Daisy Lee has over 15 years of experience in the medical device industry, both in regulatory and clinical affairs. At Veranex, Daisy provides client support in clinical operations that includes study development and start-up, site management and monitoring, and overseeing committees and vendors. She has worked in therapeutic areas involving cardiac rhythm management, cardiovascular technologies, neurosurgery, minimally invasive surgeries, and more. She was involved with harmonizing the Veranex quality management system by integrating multiple standard operating procedures to align with current regulations and requirements. She also participated in implementing a business-wide clinical trial management system to assist with workflow efficiencies and provide effective study management tools.
Véronique Treil, PhD
Director, Quality and Regulatory Affairs
Véronique is a clinical laboratory scientist, with more than 20 years’ experience in medical diagnostics and research laboratory settings. She led several hospital and private laboratories through successful quality accreditations. She held leadership roles in both Quality and Operations in an international Contract Research Organization (CRO), where she developed expertise in drug clinical trials and companion diagnostics (CDx). She led strategic development of molecular diagnostic activities in 5 international sites located in Europe, USA, China and Asia-pacific. She oversaw innovative biomarker assays validation and implementation for diagnostics use in EU and US sites. Véronique focuses on regulatory and quality support for IVDs and clinical studies operations. She brings scientific expertise in Precision Medicine, Molecular Oncology, Pharmacogenomics, Infectious Diseases, Antimicrobial Resistance, and Immunoassays. Véronique speaks French and English.
Ada Saltarski, MSc.
Sr Clinical Study Manager
Ada Saltarski is a seasoned clinical research professional with approximately 14 years of comprehensive experience in clinical investigations. She holds a master’s degree in Medical Science and a master’s degree in Pharmaceutical Science, focusing on drug discovery and development. Ada excels in managing and monitoring both single and multi-center clinical investigations across pre-market and post-market medical devices of various classifications and therapeutic indications. Her expertise encompasses contract negotiations and management, sponsor and site contact, data management, and the establishment of essential clinical investigation documents. Ada also manages applications to and communications with ethical committees and national authorities, oversees report writing, and handles ClinicalTrials.gov registrations and updates. She brings valuable experience in feasibility studies, auditing, training initiatives, and QMS review and updates. Ada maintains deep knowledge of current regulations and standards, including Regulation (EU) 2017/745 (MDR) and ISO 14155.
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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.



