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.
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 as well as regulatory compliance with global health agencies.
Atlantia offers a proven ability to meet recruitment milestones of healthy, pre-diseased and diseased participants. We have access to populations of all age groups and we are experienced in recruiting populations from 20 to 600 participants per trial on budget, and on time.
Our unique model maximises control, reduces the risk of data inconsistency, and brings a sense of assurance to our clients dealing with one competent organisation as opposed multiple contract research organisations.
At Atlantia your clinical data is at the centre of our service. When the samples are collected either during study visits or remotely they are prepared and stored at our facilities at -80*c, -20*C or refrigerated temperature and analysed by our research partners.
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.
Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.
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.
