Regulatory Expertise

Product description

Our regulatory team will work with the Sponsor(s) to submit the necessary information to the main health agencies depending on the focus: to increase sales, to obtain a health claim or as a proof of efficacy. The Atlantia team will design the trial protocol following the advice of the main regulatory agencies (EFSA & FDA). We will manage the Ethics Application from submission to approval.

Specifications

Categories	Analysis
Sales markets	Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America
Supplied from	Ireland; United States

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Trial Design

Our research team will work with the Sponsor(s) to design a successful trial depending on the focus: to increase sales, to obtain a health claim or as a proof of efficacy. After a preliminary research of the recent publications, the Atlantia team will design the trial protocol and the necessary documen...

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Trial Recruitment

Our recruitment team will work to access to the most relevant population depending on the health condition and investigational product. We recruit healthy and pre-disease populations, i.e. populations with mild conditions self-diagnosed. Our extensive database of participants allow us to recruit the ta...

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Trial Conduction

Our research team will work to deliver the trial on time on budget. Every step of the trial is conducted under our clinics in Cork (Ireland) and in Chicago (United States). Our clinical research team is composed by dieticians, nurses, project managers and doctors we control and oversee every step of th...

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Trial Analysis

Our research team in conjunction with our research academic partners will perform different analysis depending on the sponsors goals and investigational product. We have tracked records of delivering dietary and microbiome analysis, statistical analysis, biostatistics and bioinformatics. Please contact...

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Trial Reporting

Our research team will work to integrate all the work performed during the trial on a final clinical study report. We provide scientific writing expertise, health claims advice and publications preparation and submissions. Contact us to get know more about our past publications.

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