Study design is a crucial 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 study design depending on the desirable outcomes. We have experience designing acute, bioavailability, observational and interventional studies.
The golden standard for clinical research is the Double-Blind Placebo-Controlled Randomised Trial, however other designs can be proposed subject to the intervention (observational or interventional), and the objectives. Optimal trial 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 in consideration the findings of study feasibility, phase and budget.
The Clinical Trial Protocol will include
- Background information about the research topic and the investigational product;
- A comprehensive description of the objectives, the duration of the clinical study, the study 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;
- Study 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 study Project Manager and their teams will design and compile study documentation including 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.