The Contract Research Organization

The Contract Research Organization

Michelangelo Tech Srl, is a Contract Research Organization (CRO) founded in 2001 for the design, setup and management of clinical research programs in oncology, in accordance with all applicable national and international regulations and laws, in particular with the Italian Ministry Decree 15/11/2011, that established the minimum requirements to act as CRO in the field of clinical trials.

Michelangelo Tech’s research activity is conducted on behalf of and in connection with its owner Fondazione Michelangelo Onlus and Fondazione Gianni Bonadonna, as well as pharmaceutical and biotehnological companies.

Main activities for Clinical Trials implementation, conduct and reporting:

  • Scientific and Statistical input to Study Design
  • Protocol and Informed Consent Forms preparation
  • Clinical Trial Application preparation and submission to Competent Authorities and Ethics Committees
  • Clinical Trial Agreements with investigational sites
  • Overall Trial coordination
  • Medical supervision
  • Case Report Form design and Clinical Database setup
  • Clinical Data Management (including data cleaning and medical coding)
  • Management of Investigational Products supply
  • Monitoring of trial conduct at investigational sites
  • Biological samples collection
  • Trial Master File setup and maintenance
  • Pharmacovigilance
  • Quality Assurance
  • Statistical Analysis
  • Clinical Study Reporting

Michelangelo Tech’s research activity is conducted on behalf of and in connection with its owner Fondazione Michelangelo Onlus and Fondazione Gianni Bonadonna, as well as pharmaceutical and biotehnological companies.

Main activities for Clinical Trials implementation, conduct and reporting:

  • Scientific and Statistical input to Study Design
  • Protocol and Informed Consent Forms preparation
  • Clinical Trial Application preparation and submission to Competent Authorities and Ethics Committees
  • Clinical Trial Agreements with investigational sites
  • Overall Trial coordination
  • Medical supervision
  • Case Report Form design and Clinical Database setup
  • Clinical Data Management (including data cleaning and medical coding)
  • Management of Investigational Products supply
  • Monitoring of trial conduct at investigational sites
  • Biological samples collection
  • Trial Master File setup and maintenance
  • Pharmacovigilance
  • Quality Assurance
  • Statistical Analysis
  • Clinical Study Reporting

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