Here you may leave a Service Request to FINPEDMED and NORDICPEDMED. This service is intended for requests related to new pediatric clinical trials for defining feasibilities, including investigator recruitment, protocol design, and conduct of final protocols. This service is targeted to the Pharmaceutical companies, Contract Research Organizations, Regulatory Consultancy Agencies, Biomedical and Biotech companies, Medical Device companies as well as academic networks and research groups (i.e. the requester).
THE SERVICE REQUEST CATEGORIES*:
1) Basic feasibility assessment (R): New pediatric clinical trial (final or draft protocol); searching for investigators, trial sites and patients, including possible feasibility evaluation for the trial conduction in Finland and other Nordic countries. Free of charge.
2) Consultation (C): Consultation related to pediatric medicinal products (advice on; PIP´s -Pediatric Investigation Plans, protocol design, drug development, patient population evaluation etc.) via Consultation Agreement (with fee). NOTE: Consultation Agreements currently possible only in Finland.
Service Request is made in 3 steps:
- If needed, send blanc CDA prior to Service Request (via separate CDA-link)
- Select the Service Request Category* 1) or 2) and country coverage (1-5 countries)
- Fill-in the e-Service Request Form and send it (submission)
After the submission of the Service Request, FINPEDMED/NORDICPEDMED Office makes initial assessment about the nature of the request. If the request can be processed as a basic assessment without the involvement of Experts via Consultation, the Office will confirm the request by an e-mail to the requester and start the process.
- One Service Request may include only one category at the time (i.e. one trial or one consultation).
- All Services are provided FINPEDMED/NORDICPEDMED Office hours.
- Basic Service Request is free of charge for all Requesters
- Consultations are based on annually confirmed fees. See: Service Fees.
- See more: Terms of FINPEDMED/NORDICPEDMED Services.
Service Request operational model
All Service Requests are managed with same operational model, but the Consultations (C) can be excuted only in Finland.
See our operational model here (figure).
Consultations (only for Finland)
If the request includes specified tasks, such as demanding feasibilities or scientific / medical / product advice, the FINPEDMED Office will offer the possibility to use Expert consultation for the request assessment. In those cases, FINPEDMED Office will contact the requester to confirm the acceptance for the consultation and can provide Consultation Agreement template. All consultations are executed under Consultation Agreements for fee (see Service Fees).