Clinical Trial Design

Prior to the conducting of the clinical trial, the study must be approved by the Research Ethics Committee. Then a Site Initiation Visit (SIV) will be performed and the clinical staff (Medical Doctor, Research Nurses, Clinical Trials Assistant, Nutritionist, Research Technician etc.) will be...

The Atlantia Clinical Research team provides a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report, and if the client requests, a full clinical study report.Atlantia maintains no rights to Intellectual Property generated from this study...

This article will briefly discuss the many benefits of conducting a multi-centre human clinical trial, while also touching on the industry leading capabilities and processes of Atlantia Clinical Trials.

Nutraceuticals and over-the-counter (OTC) products are regulated by EFSA. The European Food Safety Authority (EFSA) states that human intervention studies are ‘central’ to health claim substantiation and are also the ‘top of the hierarchy’ that informs decisions. Just how much data is necessary to deliver a positive health claim opinion and what can we learn from tracking past published opinions of EFSA’s NDA Panel. What are the key deliverables for any human intervention study or package of human studies?

The key takeaways:
Health claims may not be quite as challenging to achieve as some people may think - as long as you design and deliver a consistent package of good quality human intervention studies. Published scientific opinions from EFSA’s NDA Panel covering previous health claim applications offer a great resource to future health claim applicants. The principle of GCP (Good Clinical Practice), is vital to delivering a study that will meet the expectations of EFSA reviewers.


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