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 scientific team works in accordance with ICH GCP Standards, Regulatory agency guides, Medical Agencies Guidelines, Ethical principles and peer-to-peer journals.
The study protocol developed by our team includes:
• 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;
Atlantia has developed a number of customised Apps to collect daily data on subject’s symptoms, compliance and AE reporting. A profile screen can let participants edit data that can change during the course of the study, such as weight. The profile screen is also used to give participants an easy way re-visit on-boarding screens, contact help & support and to view any consent/privacy policies associated with the study.