Abstract

Background: Clinical research has evolved into a multidisciplinary field integrating Medical Devices (MD), In Vitro Diagnostics (IVD), and Artificial Intelligence (AI), governed by a modernized European regulatory framework including the Clinical Trial Regulation (CTR), the Medical Device Regulation (MDR), and the In Vitro Diagnostics Regulation (IVDR). In 2021, the Istituto Oncologico Veneto (IOV) IRCCS established the Clinical Trial Quality Team (CTQT) to provide support for non-profit trials and ensure high-quality standards. Methods: A descriptive analysis of trials managed between 2021 and 2025 was conducted using the REDCap platform. A team of 15 professionals assessed performance via Key Performance Indicators (KPIs) categorized into: ethical–regulatory compliance, operational efficiency and data quality. Results: The CTQT manages 18 studies (83% interventional, 50% multicentre), primarily focused on brain (17%) and genitourinary (23%) tumours. The mean time from internal feasibility to Ethics Committee discussion is 13 days. Total approval time (ethical and administrative) is 107 days. Operational metrics are strong, with Site Initiation Time averaging 27 days and First Patient In (FPI) at 41 days. Conclusions: A centralized, multidisciplinary structure effectively supports non-profit research in a complex regulatory environment. While operational speed is high, challenges such as staff turnover and query management variability remain. Future efforts will focus on standardizing post-approval administrative phases and optimizing data management to further improve trial efficiency and integrity.

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