Support offices

Clinical trial office

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Head

Elisabetta Riva

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CSQ-IQNet_EN The Clinical Trials Office (CTO) provides regulatory, administrative and methodological support, as well as educational services to internal investigators conducting clinical trials and to investigators from the affiliated institutes. CTO also acts as the techno-scientific secretary of the institutional review board of IRCCS Ospedale San Raffaele, helping the board to perform its core evaluation activity.

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The office works in close collaboration with the scientific directorate of Ospedale San Raffaele, the institutional review board directorate, the local government of Regione Lombardia and the Italian agency for the evaluation of medicinal products (AIFA, Agenzia Italiana del Farmaco).

Clinical trial office
Clinical trial office

 

Mission

Increasing awareness and accrual to clinical trials;

Improving the quality and efficiencies of conducting clinical studies in compliance with regulatory, documentation and oversight requirements;

Supporting the institutional review board activity.

Activity

Among its core activities:

  • Technical, methodological and scientific support during trial design and submission;
  • Research monitoring and data management with ongoing trial;
  • Trial cost evaluation and economic-administrative support;
  • Training the research community about trial design and management;
  • Institutional review board support in evaluation and reporting.

Achievements

Thanks to the commitment of the Clinical Trial Office, IRCCS Ospedale San Raffaele has more than 750 ongoing clinical trials and each year more than 300 trials protocols are submitted to the hospital institutional review board (a number that has grown since 2009 by almost 50%).

This clinical research effort, coupled with the cutting-edge basic research carried out at San Raffaele, has brought to the clinical practice many innovative therapies developed within the institute labs.