Neurology
At Atlantia, we understand the intricate journey of bringing neurology drugs to the market. Our clinical trials are designed with precision to navigate through the complex landscape of neurological conditions, ensuring your product demonstrates clear, significant benefits. With a keen focus on safety and efficacy, we guide your neurology drug from early-phase studies to market, supporting your claims with solid, scientific evidence. This approach not only aids in swift regulatory approval but also fortifies your product's position in a competitive market, building a foundation of trust with healthcare providers and patients alike.
Women's Health
The path to success for women's health drugs requires a partner who values the nuanced needs of women's healthcare. Atlantia brings a specialized focus to study designs that highlight the efficacy and safety of your product, resonating deeply with women's health concerns. By aligning with regulatory standards and emphasizing patient-reported outcomes, we help you craft compelling claims that speak directly to the well-being of women. Our support in navigating regulatory pathways ensures your product not only reaches the market ready but also stands out as a trusted option for women's health, paving the way for broader acceptance and use.
Cardiac Disease
In the critical field of cardiac disease, Atlantia's expertise offers a strategic advantage. Our rigorous cardiovascular outcome trials are meticulously planned to demonstrate the life-saving potential of your cardiac disease drug. Through our comprehensive approach, we ensure that your product meets the stringent requirements of regulatory bodies, showcasing a significant reduction in adverse cardiac events. By partnering with Atlantia, you gain access to a team committed to highlighting the impactful benefits of your drug, enhancing its market readiness, and establishing it as a key player in the fight against cardiac disease.
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 ensure regulatory compliance for neurology drugs in both the EU and the US?
Atlantia leverages its extensive experience with regulatory agencies like the FDA and EMA to navigate the complex approval process for neurology drugs. Our team stays abreast of the latest regulatory guidelines and requirements, ensuring that every aspect of the drug development process, from study design to data reporting, aligns with the stringent standards set for neurological medications. This meticulous approach accelerates the path to approval while upholding the highest safety and efficacy standards.
What strategies does Atlantia use to substantiate claims for women's health drugs?
Our strategy centers around designing and executing clinical trials that not only demonstrate the efficacy and safety of women's health drugs but also highlight their impact on patients' quality of life. By incorporating patient-reported outcomes and focusing on conditions specific to women's health, we generate robust evidence that supports compelling marketing claims. This evidence is crucial for building trust with both regulators and the target demographic.
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.
What makes Atlantia’s approach to pharmaceutical clinical trials unique?
Atlantia's approach is distinguished by our commitment to scientific excellence, regulatory expertise, and patient-centered outcomes. We specialize in designing and executing trials that not only meet regulatory requirements but also provide clear, compelling evidence of a drug's benefits. Our collaboration with leading researchers and institutions further enhances our trials' credibility, ensuring that your pharmaceutical product achieves both regulatory success and market impact.
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
Start Your
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