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Clinical Trials for Medical Devices

Your Clinical Experts in Class 1 & Class 2a Trials

We conduct multinational studies spanning across a diverse range of health areas and portfolios through our cutting edge clinics in both Ireland and the USA and our medical and site network. Our adaptive team manages your clinical journey, ensuring transparency and expert guidance throughout. Our services include Clinical investigations of medical devices to assess performance, effectiveness and safety, in line with Clinical Investigation of medical devices for human subjects – Good Clinical Practice (ISO 14155:2020).

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Our Areas Of Expertise

image of blood monitor

Health Sensors & Wearable Technology

This area includes Physical Activity Trackers, Sleep Monitoring, and Hydration.

medical bandage being applied

Class I

Class I Medical Devices refers to equipment such as Pain Patches, Topicals, and Dental Devices.

phlebotomy nurse taking bloods

Class 2a

Class 2a devices include Non-Invasive Monitors, Phlebotomy Devices & Equipment, and Continuous Glucose Monitoring.

Take the First Step
Take The First Step

Discuss Your Project

Looking for a research partner to conduct your clinical study? Our expert team is here to help. Get in touch today!

What We Do

Services

Clinical Trial Design

Clinical Trial Design

Study design is a significant phase of any clinical research project. Our team works with sponsors to plan the optimal approach to your clinical research needs.

 

What's involved in Clinical Trial Design?

- Clinical Trial Budgeting
- Preliminary Research
- Study Feasibility
- Power Calculations
- Clinical Trial Protocol Development
- Study Document Preparation

Clinical Trial Regulation

Clinical Trial Regulation

Our regulatory team take into consideration the regulatory environment of the sponsor company to provide highly compliant clinical research.

 

What's involved in Clinical Trial Regulation?

- Regulation Research
- Ethics in Clinical Trials
- Claim Applications
- Structure/Function Claims
- Authorized Health Claims
- GRAS/QHC (Where applicable)

Clinical Trial Recruitment

Clinical Trial Recruitment

Atlantia offers a proven ability to meet recruitment milestones. With an extensive participant database in both the EU & the US, we can ensure you get the participants best suited to your trials needs.

 

How we Handle Trial Recruitment?

- Extensive Volunteer Database in Europe and the US.
- Patient-centric Trial Model
‍- Community Events
- Doctor Involvement
- Online Advertising
- Traditional Advertising

Clinical Trial Reporting

Clinical Trial Reporting

The Atlantia Clinical Research team provide a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report and a full clinical study report.

 

What does the Trial Close-Out Phase Include?

- Clinical Study Reports
- Publications
- Outreach Material Designs

Clinical Trial Conduct

Clinical Trial Conduct

Our unique model maximises control, reduces the risk of data inconsistency, and brings a sense of assurance to our clients dealing with one competent organisation as opposed multiple contract research organisations.

 

How to Conduct Clinical Research

- On Site Study Visits
- Project Management
- Quality Management
- Data Management
- Independent Study Monitoring
- Investigational Product Management

End-to-End Services

End-to-End Services

We are a flexible and dynamic company and we partner with our sponsors, aligning their clinical goals, to deliver the highest quality validation research in accordance to ICH-GCP standards.

 

The Clinical Trial Process

- Clinical Trial Design
- Clinical Trial Regulation
- Clinical Trial Recruitment
- Clinical Trial Reporting
- Clinical Trial Conduct
- Clinical Trial Analysis

Media & Resources

More From Atlantia

Case Studies

Case Studies

Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.

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Latest News

Latest News

Learn more about our company through our latest news. Articles have been worked on by members of our team. For media inquiries, please reach out to: marketing@atlantiatrials.com

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Publications

Publications

Many of our clinical studies conducted are translated to published research papers in some of the top nutrition journals. You can discover our latest published work under this section.

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