Romania
Our own CRAs and regulatory specialists work in Romania. As an EU member state, Romania sits under the EU Clinical Trials Regulation, with one CTIS submission covering the trial.
Country engagements
One of the eight EU member states covered by our own CRAs and regulatory specialists.
Review timelines
One CTIS submission under the EU Clinical Trials Regulation; the Romania national part runs in parallel with the other member states in the application.
Our own regulatory specialist handles the Romania national part in the local language.
What we offer there
- Our own CRAs, monitoring at site
- Our own regulatory specialists for authority and ethics submissions, in the local language
- Site identification, feasibility and qualification
- Site contracts and budget negotiation
- Import, export and clinical logistics