The Clinical Study Design, a crucial phase in nutrition research and product development
Study design is a significant phase of any clinical research project. At Atlantia we feel that our careful planning and guidance to our clients coupled with our extensive experience with regulation, pre diseased and diseased populations, is what brings our clients back time and again to trust us with their scientific validations.
Our scientific team will work with our sponsors to agree on the most suitable research design depending on the desirable outcomes. We have experience designing acute, bioavailability, observational and interventional studies.
The gold standard for clinical research is the Double-Blind Placebo-Controlled Randomised Clinical Trial, which is done to minimize the possibility of experimenter bias. However, types of clinical trial designs vary, and can be proposed subject to the intervention (observational or interventional), and the objectives.
Optimal clinical study design does not always require a randomized, double-blind, placebo-controlled trial as many types of clinical trials can yield scientifically valid results. Our scientific team will work with you on the study feasibility, design and document preparation:
Study feasibility and design
Our expert team will work to assess the study feasibility in accordance with ICH GCP Standards, Regulatory agency guides, Medical Agencies Guidelines, Ethical principles and peer-to-peer journals. The Protocol Design will be developed taking the findings of study feasibility, phase and budget into consideration.
The Clinical Trial Protocol will include
- Background information about the research topic and the investigational product;
- A comprehensive description of the objectives, duration of the study, the population, inclusion and exclusion criteria;
- The randomisation, blinding and treatment allocation, as well as the unblinding procedure if applicable;
- Investigational product formulation, packaging, labelling, handling, dosage and compliance;
- Procedures such as recruitment, screening, eligibility, visits, measurements, assessments and sample collection protocols;
- Data processing, statistical considerations, confidentiality and monitoring methods;
- Reporting and publication agreements;
Study document preparation
The Project Manager and their teams will design and compile study documentation. This includes the eCRF (electronic Case Report Form), source documents, Trial Master File (TMF), study logs and study specific SOP’s. Atlantia has developed a number of customised Apps to collect daily data on subject’s symptoms, compliance and AE reporting.
A Principal Investigator (PI) will be assigned to the study and will have final sign-off of the study protocol and ethics application. The Independent Clinical Trials Associate/Monitor will provide a monitoring plan, outlining proposed site visits and report format.