Clinical Trial Services
Service Requests may include preliminary country-specific feasibilities (very early stage) or feasibilities with complete protocol, looking for trial sites and potential investigators according to the trial protocol specifications (by the specialty, case by case).
Additionally, FINPEDMED Office may assist with more specific laboratory services and pharmacy services for the Investigational Medicinal Products. FINPEDMED provides expertise in the fields of clinical pharmacology and pharmacovigilance related to a long-term follow-up.
FINPEDMED Consultation services include also broader assessments in clinical, methodological or pharmacological questions related to drug development or protocol development processes. These tailored reviews and assessments can be done by Ad Hoc Scientific Board, which may include several Experts at the same time representing different specialties or different patient groups (e.g. adults and children). For these, FINPEDMED Office negotiates and prepares the Consultation Agreements for the Experts and for the sponsors. The agreements are signed and the Service Fees are administrated, through a separate legal entity of HUS; CRI HUCH Ltd.
In HUS area, FINPEDMED offers Clinical Trial Unit (CTU) facilities and Research Nurse Coordinator for the sponsored and academic pediatric clinical trials and research projects. The CTU is located at Park Hospital, in connection with New Children´s Hospital.
Clinical Trial Agreements
FINPEDMED does not sign any trial or consultation agreements or administrate research / trial funding. All trial related funding is administered together with the Clinical Trial Agreements (CTA) in the separate administrative units of those hospitals where the trial will be conducted in Finland. The CTA will be signed between the trial Sponsor and the hospital. In HUS, the CTAs and trial funding are administrated through CRI HUCH Ltd.