Dietary Supplements
The journey from concept to consumer shelf for dietary supplements varies greatly across the globe. With Atlantia, a spin-out of the APC Microbiome Institute, you gain an expert ally. In Europe, Atlantia navigates EFSA's stringent standards, ensuring your products are scientifically solid. For those eyeing the U.S. market, our expertise becomes your advantage in a less stringent landscape, offering rigorous, science-backed claims that set you apart in a crowded marketplace. Partner with Atlantia to confidently enter any market, knowing your supplement is backed by the highest level of scientific integrity.
Microbiome Products
The microbiome market is ripe with opportunity but demands precise scientific validation to thrive. Atlantia, a leader in microbiome research thanks to our origins in the APC Microbiome Institute, is perfectly poised to validate your product's efficacy and safety. While regulatory landscapes differ, the demand for substantiated benefits is universal. Led by our globally recognized medical director, Prof Timothy (Ted) Dinan, we leverage our unparalleled expertise to deliver compelling evidence that captures consumer interest and trust. With Atlantia, your microbiome product won't just enter the market—it will lead it, offering clear, differentiated benefits that speak directly to consumer needs.
Functional Foods & Beverages
The functional food and beverage sector thrives on innovation and proven health benefits. Atlantia transforms your visionary products into market successes, applying our evidence-based approach to distinguish your offerings and appeal to health-conscious consumers looking for products with verified benefits. Our team ensures that your functional foods and beverages not only meet scientific standards but also resonate with consumers' growing demand for health and wellness, driving your brand's growth and market penetration.
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.
Hybrid Trials
Strike the perfect balance between rigor and flexibility with our hybrid trial model. Tailored to suit the specific requirements of your study, our trials are crafted to enhance efficiency, speed, and participant involvement while keeping costs in check.
FAQ
How does Atlantia navigate regulatory compliance in the EU and the US?
Atlantia brings a wealth of knowledge in navigating the EFSA and FDA regulatory landscapes. Led by our seasoned regulatory manager, who successfully secured the first article 13.5 EFSA health claim, Atlantia is dedicated to ensuring regulatory compliance for nutraceutical products. We are committed to ensuring that your product meets all health claim regulations and safety standards by proactively staying informed of regulatory changes and using our expertise to effectively navigate these complex requirements. Our team offers full support from the initial product concept to market entry, guaranteeing compliance every step of the way.
What unique advantages does Atlantia offer in study design for nutraceuticals?
With our medical director being among the top 1% of cited research scientists in microbiome studies globally, Atlantia brings advanced scientific expertise to your nutraceutical trials. Our unique approach to study design, deeply informed by the latest research and methodologies, ensures your health claims are substantiated by undeniable scientific evidence, maximizing market impact and consumer trust.
How does Atlantia ensure marketing claims are compelling and compliant?
Atlantia combines rigorous scientific validation with strategic marketing insights to craft compelling, compliant claims for your nutraceutical products. Drawing on our extensive regulatory knowledge and scientific prowess, especially in the microbiome field, we ensure that your marketing claims stand on solid evidence, enhancing brand credibility and consumer confidence.
What is Atlantia's approach to data collection?
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 Trial 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
Ready to start your
nutraceutical clinical trial?
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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