Driving Innovation from First-in-Human to Postmarket Success
Accelerate your clinical development journey with ProPharma's full-service CRO solutions tailored to the unique challenges of medical devices, diagnostics, and combination products. From early feasibility studies to pivotal trials and postmarket surveillance, our global team of regulatory, clinical, compliance, and scientific experts deliver strategic guidance, operational excellence, and patient-focused execution—every step of the way.
All Medical Device Clinical Trial Services
Clinical trials for medical devices and diagnostics require a distinct approach from drug studies, which is why we have a dedicated team of experts focused exclusively on executing device and trials with precision, efficiency, and regulatory alignment.
Full Service CRO Capabilities
At ProPharma, we understand that MedTech innovation demands more than clinical execution—it requires a strategic partner. Our client-focused approach integrates regulatory insight, scientific rigor, and operational flexibility to advance implantables, wearables, diagnostics, and combination products across global markets.
With deep therapeutic expertise and scalable delivery models, we support companies of all sizes—from emerging startups to global manufacturers. Our customized solutions are built on collaboration, transparency, and a shared commitment to improving patient outcomes worldwide.
Early Phase Clinical Trials (First-In-Human)
Accelerating Proof-of-Concept with Confidence
Speed and precision are critical when initiating First-in-Human (FIH) trials. ProPharma delivers early phase clinical development services specifically designed to generate the data needed for clear go/no-go decisions.
- Expert protocol design by integrated regulatory, pharmacology, PK, biostatistics, and clinical teams
- Feasibility and site selection tailored to early-phase requirements
- Rapid enrollment strategies that reduce time to first dose
- Adaptive trial design and real-time data monitoring to accelerate development
Pivotal Clinical Trials
Strategic Execution for Regulatory and Commercial Success
When it’s time to scale, ProPharma helps you design and execute pivotal trials that support marketing applications and commercial goals. Our approach combines clinical excellence with strategic foresight to ensure your trial meets both regulatory and business objectives.
- Evidence generation aligned with FDA, EU MDR, and global regulatory expectations
- Competitive landscape analysis to inform design and positioning
- Operational oversight with an eye on enrollment targets, data quality, and cost efficiency
- A patient- and outcomes-centric approach tailored to your device or diagnostic product
Late-Phase Clinical Trials, Postmarket, and Real-World Evidence
Maximizing Market Access and Long-Term Success
Post-approval is just the beginning. ProPharma’s late-phase services help clients generate real-world data, monitor product safety, and optimize global market strategy. Whether for reimbursement, lifecycle management, or ongoing compliance, we support you with tailored solutions grounded in real-world needs.
- Postmarket surveillance and safety monitoring
- Global RWE and health economics strategies
- Support for payer engagement and value-based agreements
End-to-End Device Development & Regulatory Consulting Support
Integrated Expertise from Concept to Commercialization
ProPharma offers more than clinical trial execution—we provide comprehensive development and regulatory consulting services to support your product from initial concept through approval and beyond. Our cross-functional teams bring deep expertise across U.S., EU, and global frameworks, helping you navigate complex regulatory pathways and avoid costly delays.
- Strategic regulatory planning and gap assessments
- IDE, 510(k), PMA, De Novo, EU MDR, and IVDR submission support
- Combination product regulatory strategy and coordination
- CMC, labeling, and risk management consulting
- Health authority meeting preparation and representation
Whether you're launching a novel diagnostic, wearable, or combination product, ProPharma ensures your development plan is aligned, compliant, and designed for long-term success.
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Global Medical Device Experts
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Vicki Gashwiler
Global Head, Clinical Operations
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Tina Hudson
Senior Director, Diagnostics and Combination Products
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Jennifer Daudelin
Director, MedTech Regulatory / Quality
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Nick Jungbluth
Sr. Director, Medical Device and Diagnostics
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Pathways to Market for Medical Devices in the U.S.
Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...
Navigating QMS Requirements from a Medical Device Perspective
Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...
How to Manage a Drug Product in a Medical Device Environment
A global medical device company asked ProPharma to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined how it...
News & Insights
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
July 24, 2025
FDA Publishes over 200 Complete Response Letters (CRLs)
FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.
July 24, 2025
Navigating EMA and Global Regulations for Medical Information Services
ProPharma guides clients through global medical information regulatory landscapes, ensuring compliance and excellence across markets with tailored solutions, AI integration, and continuous training.
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News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
