Our services

Clinical Trial Applications

RPN supports for Clinical trial application step by step:

  • Preparation and submission of clinical trial applications and following amendments to the competent authorities and to the ethics committees; check progression of the applications until approval
  • Data entry on behalf of the sponsor into the EU and Italian Agency (“Osservatorio Nazionale sulla sperimentazione clinica dei medicinali”) databases for clinical trials
  • Paediatric investigation plan (PIP) applications:
    • Advise on the approach for PIP, deferral and/or waiver applications, according to the Paediatric Regulation
    • Support for the preparation of the relevant documentation, submission and follow-up of PIP application
    • Communications/meeting with the Paediatric Committee (PDCO)

Facilitation of local concerns via a network of partners in EU countries and USA

Consolidated network of partners in EU countries and a local Agent in the USA allow us to support our clients facing specific local issues.