FAQ

Clinical Trials are research studies that explore whether a medical strategy or treatment is effective or if the health claims associated with the product are accurate. The only way that this can be tested for effectiveness and tolerance is with the help of our volunteers.

Screening involves a series of tests or procedures designed to evaluate whether prospective participants meet the necessary criteria.

It is a clinical trial where one product is active (test product) and one is a dummy product. Participants or study staff will not know which product they receive in order to test the true effects on their own merit.

Randomisation forms the backbone of every clinical trial that compares treatments. It involves assigning participants to different treatment groups randomly, ensuring that each individual has an equal opportunity to receive any of the treatments in the clinical trial. This method enables the trial staff to make fair and well-informed decisions regarding new treatments, and is widely recognized as the most effective way to assess the efficacy of a new treatment and the impact of interventions.

We use run trials on:

• Nutraceutical products (foods, food derivatives, and food extracts)
• Medical devices
• Nutricosmetic products (oral supplementation of nutrients formulated and marketed specifically for beauty purposes)
  
• Cosmeceuticals (cosmetic products with bioactive ingredients purported to have medical benefits)
• Pharmaceuticals (mainly over-the-counter medications)
  

First, we kindly ask participants to complete a Pre-Screening Questionnaire, which we will carefully review to determine eligibility.

Following this, one of our Recruitment Officers will reach out to you. If you meet the requirements, a Telephone Screening Questionnaire will be conducted.

If you continue to meet the criteria, the next step involves visiting our clinic for further assessment.

After another evaluation of your eligibility, if you still qualify, you will be offered a spot in the study.

Before embarking on your journey in a clinical trial, it's important to familiarize yourself with a key document – the Informed Consent Form. This vital piece of literature offers valuable information about the trial you're thinking of joining. Signing this document is a mandatory step for all potential participants to officially become part of the trial.

Inclusion criteria are requirements that participants must have in order to qualify for a study.

Exclusion criteria are characteristics that disqualify participants from a study.

Each trial has its own set of Inclusion & Exclusion criteria.

A washout refers to a period of time where you are asked to stop taking any foods, supplements and/or medicinal products in order to qualify you for a study.

A washout can also refer to the period between finishing one study and beginning a new one.

Generally, we recommended 60 days between finishing one trial and beginning another, this length can differ between trials however. This is known as a “washout”.

Different sponsors from around the world come to Atlantia and request us to conduct a trial on their behalf.

Free health check – At visits we accurately measure your BMI , Blood Pressure & perform blood analysis so we can inform you on health markers such as cholesterol. The blood draw is performed by one of our research nurses or trained phlebotomists. Some trials also have added benefits such as free x-rays, DXA scans or MRI scans.

Compensation – We value our participants, therefore adequate financial compensation is given to each of our participants for their contribution. This figure varies across our studies.

Contributing to the advancement of science – Without trials it would not be possible for companies to show if foods have any beneficial effect on health. So, by taking part in trials you are enabling these companies to create new health products which can benefit everyone.

Yes, all our participants are reimbursed for the time on the study. Each studies payment amount differs. The payment method given is in the form of a cheque.

All trials are approved by our local ethics committee which is a rigorous process. This committee is made up of consultants, regulatory specialists, nurses & the general public.
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The majority of our trials use products which have no known risks or side effects. If there are any known risk associated with product they are clearly stated in the informed consent which is given to you prior to the beginning of your first visit to our clinic.
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All our staff are trained to conduct research trials according to ICH-GCP standards which ensure each participant is treated in the appropriate manner and a strict set of procedures is followed.

You can leave at any time during a study, please note however, you may not receive any reimbursement fee.

We require people that are generally healthy for studies, but we often have trials aimed at people with certain conditions such as high cholesterol, asthma, indigestion and high blood pressure.

Yes, all your information is protected according to GDPR standards.

If you wish to not be contacted by us in the future, please contact dataprotectionofficer@atlantiatrials.com with your request.

Due to the level of interest in trials, it can take some time to get in contact with everyone that has applied, so please be patient with us. If you are particularly interested in a trial, you can get in contact with us directly by phone or email and we will be happy to help.