Description
The Clinical Research Unit (CRU) is the unit within the Directorate of Clinical Research and Innovation that coordinates all departments and services involved in clinical trials, profit and nonprofit, in an integrated manner.
With organizational, management and regulatory expertise, the CRU ensures consistency, quality and continuity at every stage of trials, facilitating collaboration among researchers, sponsors and patients.
More than 200 clinical trials registered on international platforms are active at the Institute. The typology of studies is broad and diverse and includes:
- interventional studies, which evaluate the efficacy and safety of new drugs and therapeutic strategies; studies at different stages of investigational drug development are active at the Institute;
- nursing studies, focusing on the care, quality of life, and management of cancer patients;
- surgical studies, dedicated to the innovation of surgical techniques and the improvement of postoperative outcomes.
Areas of major innovation include trials on Car-T cell therapies, tumor-infiltrating lymphocyte (TIL) therapies, cancer vaccines, radioconjugates, next-generation drugs, and bispecific antibodies and drug-antibody conjugates. These approaches represent fundamental tools for transforming cancer diagnosis and treatment, opening up prospects for increasingly personalized and targeted care.
To support these strategies, the Institute is equipped with an advanced diagnostic service capable of analyzing more than 500 gene variants related to more than 28 cancer types. This level of molecular insight enables precise identification of the biological characteristics of each tumor, guiding therapeutic choice and facilitating patient access to targeted clinical trials and state-of-the-art therapies.
Through all of this, the Institute’s role is consolidated as a center of excellence in oncology research, able to offer patients access to cutting-edge therapies from the earliest stages of testing and to contribute significantly to the advancement of medicine internationally.
Mission
Ensure robust, safe and internationally standard-compliant clinical trial management through a QMS-based organizational model. The approach is based on six principles: commitment, culture, cooperation, patient-centeredness, continuous monitoring and continuous improvement.
CRU operates as a point of reference for:
- sponsors, CROs and industry partners, for the submission, activation and management of studies;
- researchers and hospital staff to conduct trials;
- patients and caregivers seeking information on active studies and innovative therapies;
- Internal offices for administrative, health and contractual processes;
- Ethics committees and regulatory authorities, to ensure full regulatory compliance.
With the work of a multidisciplinary team, the CRU supports all phases of clinical trials and strengthens the Institute’s role as a center of excellence in oncology research.
Équipe
The CRU consists of professionals with specialized expertise in clinical research, quality, regulatory, pharmacovigilance, administration and operational management of studies. The staff includes:
- Macro-areas contacts (QMS, Regulatory, Phase I, Study Management, Pharmacovigilance, Compassionate Uses and FPO-promoted Trials)
- Data managers, clinical research coordinators and administrative staff
- Dedicated team for training and internal communication
- Experimental physicians and nurses
- Doctors, nurses and health care personnel involved in the different studies
All staff work according to up-to-date SOPs, with ongoing training, in compliance with Good Clinical Practice (GCP) principles, and with an approach geared toward efficiency, transparency, and continuous improvement, in line with the Institute’s mission.