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Clinical Trial Operations
Discover QbD Group's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate.
Your trusted CRO for Medical Devices & IVDs
QbD Clinical is your trusted MD & IVD Contract Research Organization (CRO) for efficient, high-quality clinical development.
With over 10 years of experience, we specialize in designing and managing clinical studies, ensuring regulatory compliance, and accelerating your path to market.
From strategy to execution, we deliver tailored solutions to meet your clinical research needs.
CRO services for every stage of your MedTech clinical journey
From early feasibility to post-market follow-up, QbD Clinical offers end-to-end Contract Research Organization (CRO) services to accelerate the development and approval of your medical device. Our experts guide you through every step, ensuring compliance, efficiency, and high-quality results.
- Feasibility & Study Design
- Regulatory Submissions
- Medical Writing
- Data Management
- Clinical Monitoring
- Site Management
- Project Management
- Safety Management
- Supply Management
- Core Lab Management
- Quality Assurance & Compliance
- Legal Representation
Why QbD Group?
With over 10 years of experience, QbD Clinical delivers flexible, tailored clinical solutions to help bring medical devices to market efficiently while ensuring compliance with MDR and ISO 14155.
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+52 therapeutic indications
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+250 clients worldwide
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+50 countries covered
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+92 clinical experts worldwide
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+200 clinical trials
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+650 projects delivered
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+2400 clinical sites
20+ years of clinical experience
Full lifecycle support
Global presence
Best Managed Company
Clinical Medical Advisory Board
At QbD Clinical, we understand the critical importance of informed, expert guidance in the realm of clinical research and development. That’s why we’ve established our Medical Advisory Board, comprising distinguished professionals from diverse medical and scientific backgrounds.
Our Mission
Our Medical Advisory Board is at the heart of our commitment to excellence in life sciences. The board’s mission is to provide strategic oversight, ensuring that our clinical research approaches and methodologies are not just current, but at the forefront of scientific innovation. We aim to bridge the gap between advanced scientific knowledge and practical application in clinical research, thereby enhancing patient outcomes and advancing medical science.
Expertise that drives clinical success
In addition to their broad clinical and scientific backgrounds, our board members provide strategic input across key areas such as clinical gap analysis, state-of-the-art literature review, and protocol design. They help identify missing data, define clinical strategies, evaluate safety and performance, and develop solid study protocols that lead to scientifically sound and regulatory-ready outcomes.
Clinical Medical Advisory Board
At QbD Clinical, we understand the critical importance of informed, expert guidance in the realm of clinical research and development. That’s why we’ve established our Medical Advisory Board, comprising distinguished professionals from diverse medical and scientific backgrounds.
Our Mission
Our Medical Advisory Board is at the heart of our commitment to excellence in life sciences. The board’s mission is to provide strategic oversight, ensuring that our clinical research approaches and methodologies are not just current, but at the forefront of scientific innovation. We aim to bridge the gap between advanced scientific knowledge and practical application in clinical research, thereby enhancing patient outcomes and advancing medical science.
Expertise that drives clinical success
In addition to their broad clinical and scientific backgrounds, our board members provide strategic input across key areas such as clinical gap analysis, state-of-the-art literature review, and protocol design. They help identify missing data, define clinical strategies, evaluate safety and performance, and develop solid study protocols that lead to scientifically sound and regulatory-ready outcomes.
Meet the board members
Pierfrancesco Agostoni
Interventional Cardiologist
- 20+ years of experience in invasive and interventional cardiology.
- Performs 300–400 complex PCIs and ~80 TAVI procedures per year.
- Expert in CTO interventions, radial access, and advanced percutaneous techniques.
- 310+ PubMed-indexed publications and 10+ book chapters.
- International speaker, proctor, and live case performer.
- Investigator in multiple clinical trials, from first-in-man to CE-mark studies.
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.
Get in touch
Whether you’re navigating clinical trials or ensuring regulatory compliance, our experts are here to guide you every step of the way. Let’s work together to bring your medical device or IVD to market successfully.
Our offerings for Clinical in
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Market trends & challenges
The clinical research landscape is evolving rapidly, driven by stricter regulations, technological advances, and growing expectations for faster, more cost-efficient trials. Companies are under increasing pressure to demonstrate safety, efficacy, and compliance while navigating complex regulatory frameworks.
Emerging trends such as decentralized trials, digital monitoring, and real-world evidence create both opportunities and challenges for clinical teams. At the same time, global expansion requires careful coordination to ensure compliance across multiple regions.
QbD Group stays ahead of these trends with innovative, flexible, and compliant solutions. Whether you’re conducting a Phase I study or managing post-market surveillance, we provide the expertise and support you need to keep your clinical programs on track.
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Latest clinical insights
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Case study
Ensuring a smooth MDR transition for Oystershell's medical devices
The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
