Clinical Services Our Services - QbD Group

Your trusted CRO for Medical Devices & IVD

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.

Explore our clinical services

Medtech expertise

We bring a deep understanding of medical device and IVD challenges, specializing in cardiovascular, neurology, orthopedics, and infectious diseases. Unlike pharma-focused CROs, we focus on your industry, providing tailored expertise to support your success.

Trusted partner

With a strong reputation in the MedTech and IVD sectors, we offer reliable support backed by extensive regulatory knowledge, including ICH-GCP, ISO 14155, MDR, IVDR, and EU-CTR. Our commitment fosters trust and enduring partnerships.

Quality at every step

We emphasize quality throughout every stage of development, from planning to execution, reducing risks while maximizing the chances of success for your clinical trials.

Right-sized solutions on budget

Our flexible and scalable approach ensures cost-effective solutions, whether you’re a startup or an established company, helping you stay on track without compromising on quality.

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.

Explore our services

Lab Services Our Services - QbD Group (3)

Advancing clinical excellence in medical devices & IVDs

At QbD Clinical, we support the development and clinical validation of a wide range of medical devices. From early feasibility studies to post-market clinical follow-ups, we help bring safe and effective innovations to patients worldwide. No matter the complexity of your device, our team of experts ensures regulatory compliance, clinical validation, and market success.

Key therapeutic areas

We have in-depth expertise in the challenges associated with medical devices, with a focus on cardiology, vascular, neurology, and orthopedics.

Unlike CROs that primarily work with pharmaceuticals, we specialize exclusively in medical device clinical trials, offering expert support tailored to your needs.

Cardiovascular Conditions

Angiography
Atrial Fibrillation
Coronary Heart Disease
Heart Failure
Coronary Artery Bypass Graft (CABG)
Aortic Aneurysm (Abdominal, Thoracic)
Peripheral Artery Disease
Superficial Femoral Artery (SFA) Disease
Stroke

Cardiovascular Procedures

Percutaneous Coronary Intervention (PCI)
Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Mitral Valve Repair (TMVR)
Neuromodulation
Angiography

Musculoskeletal & Neuromuscular Conditions

Arthritis
Myasthenia Gravis
Bursitis
Chronic Pain

Respiratory Conditions

Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Cystic Fibrosis
Idiopathic Pulmonary Fibrosis
Sleep Apnea

Oncological Conditions

Bladder Cancer
Breast Cancer
Lymphoma
Liver Cancer (Hepatocellular Carcinoma, HCC)
Colorectal Cancer (Metastatic CRC, mCRC)
Pancreatic Cancer
Non-Small Cell Lung Cancer (NSCLC)

Orthopedic & Vascular Conditions

Bone Defects
Infrapopliteal Disease
Back Pain
Spine Surgery
Thoracolumbar Spinal Deformity
Knee Prosthesis

Metabolic Conditions

Diabetes Mellitus
Hypercholesterolemia

Neurological & Mental Health Conditions

Parkinson’s Disease
Spinal Cord Injury
Depression
Brain Aneurysm

Renal Conditions & Treatments

Nephropathic Cystinosis
Hemodialysis

Dermatological Conditions

Periorbital Wrinkles
Atopic Dermatitis

Gastrointestinal Conditions

Nonalcoholic Steatohepatitis (NASH)
Esophagitis

Infectious Diseases

COVID-19

CRO services for every stage of your 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

Need support? Contact us.

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Our offerings for Clinical in

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Clinical Study Operations

Discover QbD Group's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate.

Medical Writing for Medical Devices

Our expert team of knowledgeable writers will be happy to develop the right document for your needs, from the early phases to post-approval.

Clinical Regulatory Services

We help sponsors and manufacturers who want to perform a study in Europe (and beyond) to navigate through the MDR requirements to make sure their study gets approved by...

IVD Clinical Performance Studies

Do you need compliant clinical evidence for your IVD device? Our IVD experts are happy to support you in your IVD Performance Evaluation Studies.

Post-Market Clinical Follow-up

Ensure EU MDR 2017/745 compliance with thorough pre-market and post-market processes. Validate device safety with robust data and proactive Post-Market Surveillance...

Medical Writing for In Vitro Diagnostics

We offer writing, consulting, and documentation services for manufacturers of in vitro diagnostics and companion diagnostics

Clinical Strategy Support

We can assist manufacturers by assembling a team of experts with diverse knowledge and backgrounds, such as physicians and clinical experts, to ensure all necessary...

Clinical Pharmacovigilance Service

Ensuring comprehensive safety oversight is essential in clinical trials. Our expertise in pharmacovigilance could offer invaluable support.

Data Management and Analysis

Clinical data management leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. The clinical data manager oversees the...

Clinical Safety Management

Ensure safety and compliance in clinical trials with QbD Group’s expert Clinical Safety Management solutions. Tailored to meet your trial needs.

Clinical Evidence Support

Our device compliance team has the expertise to address any question or need related to clinical evidence and technical documentation of your IVD.

Clinical Quality Services

Looking for support in setting up your clinical Quality Management System (QMS), revision of Standard Operating Procedures (SOPs) or an audit? QbD Clinical is your...

Clinical Expert Services

Are you looking for research professionals to support your clinical study under your own management or in an FSP (functional service provider) model? Our expert team of...

Why QbD Group?

QbD Group combines more than 10 years of experience with flexible, tailored clinical solutions to help you bring products to market efficiently and compliantly.

What sets us apart?

Proven expertise: Over a decade of clinical experience across industries.
Global reach: Regulatory expertise across multiple markets.
Tailored solutions: Flexible support to match your specific project needs.
Full lifecycle support: From study design to post-market follow-up, we’re with you every step of the way.

Partner with QbD Group for clinical services that deliver results.

Get in touch

10+ years of experience

Full lifecycle support

Global presence

Best Managed Company

Trusted by life sciences experts

At QbD Clinical, we take pride in delivering high-quality solutions tailored to our clients’ needs. From clinical trial management to regulatory support, our experts ensure smooth and successful projects.

But don’t just take our word for it, see what our clients have to say!

⭐ 4.5/5 average rating: excellence in clinical support

With a deep understanding of the life sciences industry, QbD Clinical consistently delivers outstanding service. Our clients recognize us for our expertise, proactive approach, and commitment to quality. This is reflected in our 4.5/5 average rating, based on feedback across key areas of collaboration.

Client performance scores

4.8/5

for our expertise

4.6/5

for willingness to reuse our services

4.6/5

for communication and responsiveness

4.6/5

for meeting needs and project goals

4.5/5

for recommending our services to others

4.6/5

for meeting quality expectation

4.5/5

for a timely first response

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.

Latest clinical insights

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Blog

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

With the introduction of the Medical Device Regulation (MDR), the...

Blog

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

It shouldn’t be a surprise that today, “Near-Patient Testing (NPT)” and...

Blog

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

In the European regulatory landscape, conducting performance studies for in...

Blog

What are the requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?

What is a Clinical Performance Study? A clinical performance study...

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