Clinical Services Our Services - QbD Group

Your trusted CRO

QbD Clinical is your trusted 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.

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Lab Services Our Services - QbD Group (3)

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.

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 Pharmacovigilance Service

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

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...

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...

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 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.

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 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 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

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

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

How to define your Clinical Performance Strategy?

1. Start with a clear intended purpose A strong clinical...

Blog

The Holy Grail: Achieving Inspection Readiness

In a previous blog post, we talked about the various activities...

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