Clinical Trial Office

Clinical trial office

The Clinical Trial Office (CTO) oversees and manages clinical trials across all development phases, encompassing both sponsored and non-profit studies. Its responsibilities include conducting feasibility assessments with the support of an ad hoc Technical-Scientific Committee. These assessments evaluate potential study sites, timelines, costs, and the risks associated with the trial. The CTO also prepares all required documentation for the trial, such as the Study Protocol, Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD), informed consent forms, Privacy Statement, and patient recruitment materials.

The CTO coordinates the preparation of interim and final trial reports and develops Operational Manuals to guide study management, including the Project Gantt, Project Plan, and Monitoring Plan. It also facilitates communication with participating clinical sites to gather the essential documents required for the submission of the Clinical Trial Application (CTA).

In its interactions with regulatory authorities, the CTO manages the AIFA Observatory (OsSC – AIFA Database) and other clinical trial registries, ensuring seamless communication with AIFA, ISS, Ethics Committees, and foreign regulatory authorities for international multicenter studies. This role includes coordinating with the organization’s Ethics Committee, preparing regulatory submission packages for the CTA, and maintaining a comprehensive archive of trial documentation through to completion.

Operationally, the CTO organizes trial meetings, oversees study monitoring and pharmacovigilance through a dedicated Eudravigilance team, and manages investigational medicinal products. Additionally, the CTO handles data management and statistical analysis of trial data and conducts audits to ensure the integrity of ongoing studies.

The CTO adheres to Standard Operating Procedures (SOPs) established by the Clinical Trial Quality Team Unit (CTQT), which is an integral component of the office. The CTQT plays a pivotal role in executing Phase I non-profit studies in full compliance with the Ministerial Decree of June 19, 2015 (Decree No. 809/2015).