Clinical Services  Our Services - QbD Group

Your trusted CRO for Medical Devices & IVD

Labmark 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.

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.

 

Advancing clinical excellence in medical devices & IVDs

At Labamrk 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.
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Medical Device CRO

Industry - In Vitro Diagnostics - QbD Group

In Vitro Diagnostics CRO

IVD_Companion Diagnostics (CDx) Support

Companion Diagnostics

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

Orthopedic & Vascular Conditions

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

Neurological & Mental Health Conditions

  • Parkinson’s Disease
  • Spinal Cord Injury
  • Depression
  • Brain Aneurysm

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)

Infectious Diseases

  • COVID-19
  • Marburg Virus
  • Pneumonia
  • HIV/AIDS
  • Tuberculosis
  • Malaria
  • Diarrhea
  • Typhoid

CRO services for every stage of your clinical journey

From early feasibility to post-market follow-up, labmarkdx 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

Trusted by life sciences experts

At Labamrk 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, labmark 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

Customer feedback 2025 (7)

4.8/5

for our expertise
Customer feedback 2025 (8)

4.6/5

for willingness to reuse our services
Customer feedback 2025 (9)

4.6/5

for communication and responsiveness
Customer feedback 2025 (10)

4.6/5

for meeting needs and project goals
Customer feedback 2025 (11)

4.5/5

for recommending our services to others
Customer feedback 2025 (12)

4.6/5

for meeting quality expectation
Customer feedback 2025 (13)

4.5/5

for a timely first response

 

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.
 
Labmark 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.

Our offerings for Clinical in

Clinical Trial Operations

Clinical Trial Operations

Discover Labmark's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate.
Medical Writing for Medical Devices

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

Clinical Regulatory Services

We help sponsors and manufacturers who want to perform a study in East Africa (and beyond) to navigate through the MDR requirements to make sure their study gets approved by...
IVD Clinical Performance Studies

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

Post-Market Clinical Follow-up

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

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...
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Why Labmark?

labamark 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 labmark for clinical services that deliver results.

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10+ years of experience

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Full lifecycle support

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Global presence

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Best Managed Company