Country feasibility provide answers to whether studies with medicinal products, medical devices or other types of interventions are feasible in Sweden.
Country Feasibility submitted with the digital service
Clinical Studies Sweden's Country Feasibility service has been designed to provide you with valuable answers to your feasibility questions quickly and easily. When submitting a Country Feasibility, we ask you to indicate, among other things, the title of the study, the therapeutic area, the investigational product/medical device, and the planned start date In addition, you need to attach a brief study/protocol synopsis that is detailed enough for the experts to assess the feasibility of the study in Sweden.
Standardised questions speed up responses
The experts assess feasibility by answering a number of standardised questions. By using standardised and delimited questions, the response time is shortened, and the response rate is increased. The experts answer questions such as whether the study design is compatible with Swedish therapy guidelines, whether the patient population is present and whether the conditions are right to recruit the desired number of patients. In addition, the experts have the opportunity to provide overall feedback on the study design. Experts can also register their interest in participating in the study.
Please note that company-specific Confidentiality Disclosure Agreements (CDAs) are not signed at this stage. Reference can be made to the healthcare confidentiality legislation, please see Statement of the Swedish Association of the Pharmaceutical Industry (LIF) External link. on confidentiality protection in relation to public authorities under the Public Access to Information and Secrecy Act (OLS, 2009:400) and proposed standard text for reference.