Validate Your Medical Device with Confidence
In the high-stakes realm of medical device development, uncertainty can stall your product's journey to market. Inadequate validation not only risks non-compliance but can diminish trust in your device’s reliability and effectiveness. Leverage our global expertise and flexible trial designs to transform the intricate process into a streamlined pathway tailored to your device's success.
Clinically Proven, Market Ready
Whether you need to show proof of efficacy or comply with MDR or FDA regulations, Atlantia designs, recruits, and executes rigorous device investigations to the standard required by notified bodies and regulatory authorities. Leverage Atlantia’s conclusive validation to not just reach the market, but to lead it with a device proven to be safe and effective.
Efficacy Across Borders
Choose from our range of remote, hybrid, or full clinical trial designs tailored to meet your specific requirements and budget constraints.
We conduct trials for companies worldwide at our cutting-edge facilities in Cork, Ireland, and Chicago, USA, tapping into our extensive database of 39,000 participants, including healthy, pre-diseased, and diseased participants, all eager to participate.
SOLUTIONS
The Atlantia Difference
Expert Team
Our team of expert clinical research professionals is well-versed in the ICH-GCP standard and brings a wealth of knowledge in medical, data quality science, and regulatory compliance.
Owned Facilities
We own and operate two cutting-edge clinical facilities, one located in Cork, Ireland, and the other in Chicago, USA. Our facilities feature private consultation rooms, central phlebotomy/PK areas, and specialized equipment such as DXA and bioimpedance machines.
Medical Network
We collaborate with private hospital groups and medical organizations that offer specialized medical supervision and patient referrals for specific patient-focused trials. Whether serving as a CRO, recruitment site, or both, we help you optimize your resources and time effectively.
FAQ
What are clinical investigations?
A clinical investigation of a medical device is a research study which involves human subjects and aims to evaluate the safety or effectiveness of the device for its intended use. Clinical investigations are required for certain types of medical devices before they can be marketed or used in clinical practice.
Clinical validation is the process of demonstrating that a medical device is safe and effective for its intended use and target population.
How do I get an investigation done?
Conducting a clinical investigation for a medical device is a complex process that requires meticulous planning, execution, and adherence to regulatory standards. Working with a Contract Research Organization (CRO) can significantly streamline this process.
A CRO can streamline your medical device's clinical investigation through expert assistance in study design, regulatory guidance, advanced technology recommendations, patient recruitment strategies, budget management, and operational execution. They ensure compliance, efficient recruitment, and data integrity. Clear communication and defined expectations are key to a successful partnership.
How can Atlantia help?
We use gold standard clinical measurements to validate and verify your data from both quantitative and qualitative clinical outcomes. We can test a host of endpoints from blood, stool, urine, saliva and other outputs. We work with a range of validated tools to assess and quantify patient reported outcomes across a vast array of measurement parameters. Data can be collected directly from patients or through validated tools to report on outcomes.
Our Clinical Investigation Process
Study design is a significant phase of any clinical research project. At Atlantia we can plan and guide you to design a successful trial depending on your focus: to increase sales, obtain a health claim, or as a proof of efficacy.
Step 1
Our regulatory services include ethical submissions and approvals, our team takes into account the regulatory environment of your organisation to provide highly compliant study design.
Step 2
Atlantia excels in meeting recruitment milestones with a track record of success. Our access to diverse populations of all ages allows us to efficiently recruit anywhere from 20 to 600 participants per trial, always staying on time and on budget.
Step 3
Our unique model boosts control, reduces the risk of data discrepancies, and gives our clients peace of mind by centralizing services within one expert organization rather than multiple contract research organizations.
Step 4
At Atlantia your clinical data is at the centre of our service. When the samples are collected either during study visits or remotely they are prepared and stored at our facilities at -80*c, -20*C or refrigerated temperature and analysed by our research partners.
Step 5
At Atlantia Clinical Research, our team offers a thorough study reporting service. Our statisticians follow ICH-GCP standards to create a detailed statistical study report, and upon request, we can provide a complete clinical study report as well.
Step 6
Launch Your
Clinical Investigation
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Operating Internationally
Chicago, USA
+1 312 535 9440
142 E Ontario St #1200, Chicago, IL 60611
Cork, Ireland
+353 21 430 7442
Heron House, Blackpool Retail Park, Cork T23 R50R