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ISIDORe project home / Services / REGULATORY ADVICE, TRIAL PREPARATION & ACCESS TO CLINICAL TRIALS

REGULATORY ADVICE, TRIAL PREPARATION & ACCESS TO EUROPEAN CLINICAL TRIALS

Bring your medial countermeasure to patients.

SERVICES PROVIDED TO YOU BY: EATRIS, ECRIN & Transvac

ADVICE SERVICES

Provided to you by: ECRIN & EATRIS

Contact
David Morrow
davidmorrow@eatris.eu

Regulatory oversight & advice

  • Assessment of regulatory requirement for marketing authorization
  • Scientific advice for preparing an application to the European Medicines Agency
  • Informal scientific advice with selected national competent authorities, for highly complex projects
    • Pre-clinical and clinical development plan development – Target Product Profile (TPP) and Investigational Medicinal Product Dossier (IMPD)
    • Regulatory requirements for trial authorization and subsequent amendments by competent authorities and ethics committees, fast track procedures, coordinated authorization

Protocol design & trial planning

  • Support for clinical trial methodology, selection of trial design, endpoints and core outcome measures
  • Support for the selection of participating countries and sites
  • Planning of clinical trial operations
    This service includes management of regulatory & ethical approvals, management of informed consent for primary and secondary use, data monitoring plan, data management plan, data sharing plan
  • Support on the main outlines of funding application

ACCESS TO EUROPEAN CLINICAL TRIALS

Provided to you by: ECRIN

Contact
Christine KUBIAK
christine.kubiak@ecrin.org

Implementation of a new intervention arm

This service offers to support the implementation of new intervention arms in one of the EU‑funded adaptive platform trials, including: operational management services (regulatory & ethical approvals of protocol amendments, Investigational Medicinal Product management, pharmacovigilance, data management, monitoring, etc.) and investigation costs

Adaptative platform trials available: