Clinical Trial Operations
Discover QbD Group's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate.
Full-Service Medical Device CRO
QbD Clinical is a full-service CRO dedicated to medical device companies. From early feasibility and pilot studies to global clinical trials across Europe, North America, and APAC, and until PMCF studies, we accompany our sponsors in bringing safe, effective devices to patients on time and on budget.
Through a combination of in-house expertise and trusted international partnerships, our clients benefit from our team's deep expertise at every step of their clinical investigation. We help sponsors navigate EU MDR and FDA requirements, ensuring compliant, efficient, and patient‑centric clinical investigations aligned with their market‑access strategy.
Whether you are planning a European study or a global clinical investigation, we act as your single partner from strategy through execution, enabling clearer communication, smoother operations, and faster results.
Neurology
Expertise in neurological devices, stroke technologies, and neuro-monitoring solutions.
Orthopedic
Studies for orthopedic implants, musculoskeletal devices, and rehabilitation technologies.
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Meet our experts
Conducting clinical trials for medical devices requires a unique combination of regulatory insight, clinical expertise, and a deep understanding of device-specific requirements. At QbD Clinical, our experts are committed to designing and managing high-quality, cost-efficient clinical investigations that meet both regulatory expectations and your business goals.
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Julie Hendrickx
MD CRO Project Management Lead
20+ years clinical project delivery experience.
- International experience in Pharma and MD field
- 8+ years as Clinical Project Manager
- Project Management from study start-up to close-out
Petra De Geest
Medical Affairs Manager – Medical writing & Safety expert
12 years experience in MD field.
- MD clinical evidence and medical writing (Class I to Class III, including MDSW and AI-driven MDSW)
- Safety Management in MD clinical investigations
- Strategic leadership & consultancy
Sarah Andries
Clinical Regulatory Manager
12 years of experience in MD field.
- 10 years in Clinical Regulatory
- Regulatory Authority & Ethics committee submissions
- MDR & National legislations and requirements (EU)
- EU Legal Representative
Meet the Advisory Board
Our Medical Advisory Board brings together experienced life sciences professionals who provide expert guidance on clinical strategy, patient safety, scientific rigor, and regulatory compliance.
Pierfrancesco Agostoni
Interventional Cardiologist
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20+ years of experience in invasive and interventional cardiology.
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Performs 300–400 complex PCIs and ~80 TAVI procedures per year.
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Expert in CTO interventions, radial access, and advanced percutaneous techniques.
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310+ PubMed-indexed publications and 10+ book chapters.
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International speaker, proctor, and live case performer.
Gijs Klarenbeek
Physician & Clinical Development Expert
- Medical doctor with training in general surgery.
- Extensive experience in clinical development and regulatory approval of medical devices.
- Hands-on background in surgery and orthopaedics.
- Therapeutic expertise in cardiovascular, respiratory, oncology, diabetes, thrombosis, anti-infectives, and musculoskeletal diseases.
Djordje Lazovic
Orthopedic Surgeon & Professor
- Professor at the European Medical School Oldenburg-Groningen.
- Specialized in knee surgery, endoprosthetics, and surgical navigation.
- Combines clinical expertise with academic leadership in orthopedic innovation.
Recent client cases: real-world results across therapeutic areas
Explore some of our recent studies and projects, ranging from SaMD and heart failure to stroke and osteoarthritis. Our support spans across continents and trial phases.
