Start up, EC & CA Regulatory submissions

All the procedures for clinical trial approvals

We manage preliminary contacts with sites and ethical committees, followed by accurate set up of necessary documentation and diligent follow-up of process until authorisations are obtained, with maximum speed and accuracy.

We are highly specialised and experienced in:

  • continuously updated EC databases
  • Osservatorio per la Sperimentazione Clinica dei Medicinali (OsSC)
  • preparation of documentation required to obtain parere unico (sole opinion)
  • preparation and management of requests for authorization
  • set up of regulatory packages, with personalised graphics
  • translation and adjustment of subject information sheets, consents, synopses and any other documents, with back translation into the original language