Clinical Trial Management

We manage all types of studies:

  • Observational studies

  • Profit and non-profit interventional studies with IMP in compliance with the Ministerial Decree 15.11.2011

  • Medical device studies

Clinical Trial submission

Our team takes care of the ethical and regulatory submissions to the Ethics Committees and Competent Authorities. For us every step counts and we apply accuracy and know-how.

Monitoring

We perform all monitoring activities for sponsored and non-profit studies, from phase I through phase IV, verifying that each single activity is conducted in compliance with applicable regulations. We offer study file setup, and CRF design, as well as a tailored-made Informed Consent Form to suit each individual study, in line with local regulatory and sponsor requirements, and written in such a way that it is effective and easy to grasp for patients.

Our mantra is communication; we achieve set objectives through the constant collaboration and interaction amongst our team, the Sponsor and the Experimental Centre. We guarantee you have a clear picture of what is happening.