Service Request
  • CDA
  • Request type
  • Request summary
  • Sender Contact information and Submission

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 on pediatric medicinal product development (early phase, PIP´s -Pediatric Investigation Plans; draft protocols; drug development) via Consultation Agreement (with fee). NOTE: Consultation Agreements currently possible only in Finland.

Service Request is made in 3 steps:

  1. If needed, send blanc CDA prior to Service Request (via separate CDA-link)
  2. Select the Service Request Category* 1) or 2) and country coverage (1-5 countries)
  3. 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.

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 services for the request assessment. In those cases, FINPEDMED Office will contact the requester to confirm the acceptance for the consultations and can provide Consultation Agreement template. All consultations are executed under Consultation Agreements for fee (see Service Fees).

  • 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.

Need for Confidentiality Agreement prior to generating a Service Request?

Yes

Service Request
  • CDA
  • Request type
  • Request summary
  • Sender Contact information and Submission

Request for the following Expert Services

[*] Required information
[**] Public information for the Public Notifications of Service Requests. See Terms of FINPEDMED Services article 4.0

Service Request
  • CDA
  • Request type
  • Request summary (C)
  • Sender Contact information and Submission

Please add all available attachments, e.g. trial synopsis, trial protocol, feasibility form or other relevant documents.

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Service Request
  • CDA
  • Request type
  • Request summary (R)
  • Sender Contact information and Submission

Estimated time schedule

Trial Design

Recruitment target numbers; global and local (per site)

Main objective(s)

Please add all available attachments, e.g. trial synopsis, trial protocol, feasibility form or other relevant documents.

Max filesize 2.0 mb
Max filesize 2.0 mb
Max filesize 2.0 mb
Max filesize 2.0 mb

Service Request
  • CDA
  • Request type
  • Request summary
  • Sender Contact information and Submission