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.
Many types of clinical trials can yield scientifically valid results. We provide you with a detailed breakdown of the study budget based on your requirements.
We help you to understand what research has been completed up to date, with regards to your product and health area of interest.
Our expert team will work to assess the study feasibility in accordance with ICH GCP Standards, ethical principles, regulatory and medical agency guidelines, your budget and the preliminary research.
Studies designed by our team ideally include a statistical calculation to estimate how many participants are needed in the trial in order to gather significant results.
We develop a comprehensive plan with the input of our multidisciplinary experts and the sponsor. This document will be the main guide for all the trial activities.
Clinical trial documentation includes the eCRF (electronic Case Report Form), source documents, Trial Master File (TMF), study logs and study specific Standard Operating Procedures (SOP’s).
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.
Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.