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Shauni Fitzgerald

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Shauni Fitzgerald, a seasoned Regulatory Affairs & Research Manager at Atlantia Clinical Trials, excels in clinical study design, regulatory submissions, and quality management. With a master's in Nutritional Sciences, she brings expertise and leadership to the field.

Blog Post by Shauni Fitzgerald

Shauni FitzgeraldJul 16, 2024 10:50:48 PM10 min read

Observational Study vs. Clinical Trial

There are two main types of clinical trials: observational and interventional studies. ...
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Shauni FitzgeraldJul 16, 2024 10:43:54 PM11 min read

How to Recruit Patients for Clinical Trials

Recruiting patients for clinical trials can be a major challenge for researchers and ...
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Shauni FitzgeraldJul 5, 2024 10:47:16 PM17 min read

Preclinical Trials vs Clinical Trials

Before a new intervention can be tested in human clinical trials, it undergoes extensive ...
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Shauni FitzgeraldJun 11, 2024 4:21:39 AM6 min read

What Is a Phase 2 Clinical Trial?

Phase 2 clinical trials are crucial in medical research. They bridge the gap between ...
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Shauni FitzgeraldJun 9, 2024 9:30:00 AM14 min read

Pragmatic Clinical Trial vs Randomized Clinical Trial

In clinical research, there are two main types of trials: pragmatic and randomized.
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Shauni FitzgeraldJun 9, 2024 4:05:19 AM18 min read

Epidemiological Study vs Clinical Trial

Epidemiological studies and clinical trials are research methods used in healthcare. ...
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Shauni FitzgeraldJun 7, 2024 4:13:58 AM6 min read

What Is a Phase 1 Clinical Trial?

Phase 1 clinical trials represent the initial stage in testing new medical interventions ...
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Shauni FitzgeraldJun 7, 2024 4:04:56 AM8 min read

Metabolic Syndrome Studies

Metabolic syndrome—a health concern involving obesity, high blood pressure, insulin ...
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Shauni FitzgeraldJun 4, 2024 2:23:25 PM5 min read

How Long Do Clinical Trials Last?

Introduction: Understanding clinical trials involves knowing their timelines and ...
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Shauni FitzgeraldMay 30, 2024 3:34:58 PM8 min read

Average Cost of Clinical Trials for Medical Devices

In the dynamic field of healthcare innovation, conducting clinical trials for medical ...
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Shauni FitzgeraldMay 30, 2024 6:32:10 AM18 min read

What Are Endpoints in Clinical Trials?

Endpoints are the key measures used to determine the success or failure of a clinical ...
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Shauni FitzgeraldMay 28, 2024 2:16:13 AM7 min read

Why Are Placebos Used in Trials?

In clinical trials, the quest for effective treatments meets the intricacies of ...
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Shauni FitzgeraldMay 22, 2024 11:35:40 AM6 min read

Understanding EFSA Health Claim Validation Changes

Understanding EFSA Health Claim Validation Changes
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Shauni FitzgeraldMay 21, 2024 3:37:42 PM6 min read

What's involved in EFSA notifications

The EU's Transparency Regulation has introduced new requirements for notifying EFSA about ...
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Shauni FitzgeraldMay 21, 2024 11:45:35 AM6 min read

What Makes Your Product Unique

It can be difficult to navigate the complicated world of health claim submissions, but ...
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Shauni FitzgeraldMay 21, 2024 10:56:10 AM8 min read

Defining Target Populations for Winning Health Claims

Defining the appropriate target population is a crucial step in substantiating health ...
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Shauni FitzgeraldMay 20, 2024 5:43:35 PM12 min read

Designing Real-World Criteria for Women's Health Studies

Women's health research is crucial for addressing unique health challenges faced by ...
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Shauni FitzgeraldMay 17, 2024 2:29:05 PM6 min read

Top 5 Statistical Analysis Tips for Successful EFSA Health Claims

In recent years, EFSA (European Food Safety Authority) opinions have placed a greater ...
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Shauni FitzgeraldMay 17, 2024 1:58:44 PM5 min read

Optimizing Study Design: Selecting Primary and Secondary Outcomes

Designing a successful clinical study requires careful consideration of your study ...
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Shauni FitzgeraldMay 17, 2024 12:56:00 PM5 min read

EFSA's Methodological Limitations in Human Intervention Studies

Understanding EFSA's Methodological Limitations in Human Intervention Studies Navigating ...
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Shauni FitzgeraldMay 17, 2024 12:12:01 PM5 min read

Challenges of Global Studies in EFSA Health Claims: Key Considerations

Navigating Global Studies in EFSA Health Claim Applications
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Shauni FitzgeraldMay 6, 2024 10:07:31 PM5 min read

What Is a Phase 4 Clinical Trial?

The Phase 4 clinical trial is the end of the drug-making process, a comprehensive ...
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Shauni FitzgeraldApr 30, 2024 10:32:59 PM8 min read

Are Nutraceuticals Regulated by the FDA?

In the quest for improved health and wellness, many turn to nutraceuticals. These are a ...
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Shauni FitzgeraldApr 30, 2024 10:26:00 PM8 min read

What Is Video Endoscopy?

Video endoscopy has redefined the landscape of diagnostic medicine, representing a mix of ...
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Shauni FitzgeraldApr 30, 2024 10:19:23 PM7 min read

What Does Parallel Group Mean in Clinical Trials?

In clinical trials, “parallel group” refers to a study design where participants are ...
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Shauni FitzgeraldApr 30, 2024 10:14:49 PM9 min read

What is the Difference Between Nutraceuticals and Pharmaceuticals?

In recent years, the healthcare landscape has witnessed the emergence of products ...
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Shauni FitzgeraldApr 8, 2024 3:34:49 PM5 min read

The Secret to EFSA Health Claims: How Many Studies do you Really need?

Navigating the complex world of EFSA health claims can be a daunting task, but our expert ...
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Shauni FitzgeraldApr 2, 2024 8:15:43 PM5 min read

How Long Does a Phase 3 Clinical Trial Last?

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Shauni FitzgeraldApr 2, 2024 8:07:15 PM6 min read

What is EDC in Clinical Trials?

Clinical trials are the backbone of medical research, and in recent years, Electronic ...
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Shauni FitzgeraldMar 15, 2024 3:38:56 PM7 min read

How To Design A Clinical Trial Protocol

In the world of research, a clinical trial (CT) protocol serves as the blueprint that ...
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Shauni FitzgeraldAug 23, 2023 12:00:00 AM4 min read

Defining Clinical Trial Phases in Nutraceutical Research

The study design that you choose to test your product needs to support the final claim ...
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