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