Phase I clinical trials
Founded in 2014, the START Madrid Unit at Fundación Jiménez Díaz University Hospital – Quirónsalud —the first START facility in a public university hospital in Europe— serves as the gateway between preclinical and clinical research. Under the direction of Dr. Víctor Moreno, its primary goal is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetic/pharmacodynamic profile of new drugs or therapeutic combinations in first-in-human studies.
The unit operates under strict Good Clinical Practice (GCP) standards and is equipped with facilities for treatment administration, continuous monitoring, and real-time sample processing laboratories. It is fully integrated into the hospital’s translational research network and collaborates with pharmaceutical and biotechnology companies to design adaptive protocols that expedite decision-making on recommended dosing for subsequent trial phases.
The multidisciplinary team has expanded to include seven principal investigators, over 60 clinical research professionals, a drug development fellowship program, and a dedicated hematologic malignancies group. Specialized nursing staff, research pharmacists, data managers, coordinators, and regulatory affairs experts ensure full compliance with these complex research protocols.
The unit’s key trial lines include first-in-human precision oncology studies, cell and gene therapies, combined immunotherapy platforms, agents targeting rare molecular alterations, and dose-escalation/acceleration protocols incorporating exploratory biomarkers and integrated omics analyses—fostering a continuous flow of therapeutic innovation.