All types of trials can yield valuable scientific evidence when used appropriately to test various hypotheses or to observe various food or drug effects in humans. Each clinical trial type requires specific clinical trial methods and data analysis. Randomised Clinical Trials (RCTs) can be designed to test for “superiority” (one is better than the other), “non-inferiority” (one is not worse than the other) or “equivalence” (one cannot be differentiated from the other) among other study designs.
Parallel-group, crossover, cluster, or factorial design.
Single, double, triple, quadruple blinding
Observational or interventional
Open labelled, placebo controlled, comparator controlled
Randomized or not randomized
Bioavailability, safety and tolerance, structure or function claim.
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Randomised Human Clinical Trials (RCT's) are considered the gold standard of evidence for the scientific substantiation of claims by many regulatory bodies such as EFSA & FDA.
RCTs involve randomly assigning participants to two or more groups (an experimental group and a control group) and comparing the outcomes of the groups to determine the effectiveness of a treatment or intervention.
RCT's add medical knowledge & provide effectiveness of interventions for disease prevention. However, optimal trial design does not always require a randomized, double-blind, placebo-controlled trial (many types of clinical trials can yield scientifically valid results). Our team understands the difference in clinical study design and we advise our sponsors on the most suitable type for their goal.
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, to obtain a health claim or as a proof of efficacy.
Our regulatory services include ethical submissions and approvals, our team takes into account the regulatory environment of the sponsor company to provide highly compliant study design.
Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.
Learn more about our company through our latest news. Articles have been worked on by members of our team. For media inquiries, please reach out to: marketing@atlantiatrials.com
Many of our clinical studies conducted are translated to published research papers in some of the top nutrition journals. You can discover our latest published work under this section.
