FINPEDMED Expert services are provided by all experts, representing 23 different specialties in the field of drug development and clinical trials. The FINPEDMED Office intermediates the Service Requests to the Experts who are responsible for evaluating and answering these assigned to them, and the Experts in turn replies to those. The Experts services are based on Terms of FINPEDMED Services.
Experts do not have roles of the regulatory authority, therefore not providing any official decisions and they are not binding in any respect. Experts act as independent individuals, representing the respective pediatric specialty or subspecialty and give opinions as FINPEDMED Expert members. All Experts are obliged to comply with confidentiality and data protection requirements. The Experts are not allowed to use the Service Request data for other purposes or disclose it to any third parties other than potential sub-investigators or research staff at the Trial Site/Clinic solely for the purpose of providing the Services.
Experts can give opinions on pediatric clinical trial protocols and trial feasibilities reflecting these from the point of view of medical practice, standard of care, disease prevalence, the number of patients, and general feasibility in Finland. The requester (i.e. the Sponsor) decides how many Experts are needed and how many subspecialties need to be represented in the assignment. The Confidentiality Agreements as well as Declaration of Interests of Experts will be provided on sponsor´s separate request.
Expert Service description: FPM-G-002-EN-FINPEDMED-Expert-Service-description_v2.0_2020