SR-Tiget Clinical Trial Office
The SR‐Tiget Clinical Trial Office (TCTO) was set up in 2010 as part of the Clinical Research Unit (CRU) to give support for the management of SR-Tiget clinical trials. The TCTO follows the institutional research mission, applying its principles to all patients enrolled in clinical trials, in compliance with applicable law and principles. The Office contributes to advance projects from research to clinical settings by end to end management of the clinical trials through the creation, approval, management, organization and closure of clinical trials conducted in the CRU. In addition, the TCTO sets and manages biological sample studies aimed to get biological data for SR-Tiget research studies conducted internally or as part of Institute collaboration, expanded access programs, internal observational studies or interventional trials sponsored by industrial partners or other third party. The TCTO also serves as a reference point for internal committees (Ethical Committees, OSR Clinical Research Office, Pharmacovigilance Office) and external Authorities (EMA, AIFA, ISS, Ministry of Health), implements and maintains standard operating procedures, and acts as a reference for quality related aspects of clinical research, ethical issues and privacy.
The Office consists of several functions and different expertise for the end-to-end clinical study management, from protocol definition to study set-up and conduct, ethical and regulatory submission, contract and vendor management, clinical monitoring and data management. Specifically:
- the Quality Assurance Manager and the Quality Assurance manage the quality system of TCTO, periodically evaluating the operating performance of the research group;
- Clinical Research Nurses take care of the patients during the whole study period, planning and organizing the study procedures and communicating with the nursing staff of the relevant units/departments; they also manage biological samples, and collection and storage of data provided by the investigator;
- Clinical Research Associates monitor the study to ensure it is conducted as per approved protocol and in compliance with GCP (Good Clinical Practices) regulation, and verifies data quality and patient’s rights;
- the Clinical Study Manager is the TCTO responsible person for the overall conduct and management of the study and acts as reference point in a specific clinical trial interacting with sponsor and external vendor;
- Regulatory Affairs Officers prepare and submit clinical study documentation to Ethics Committee and Regulatory Authorities, and maintain the documentation of the study;
- Data Managers organize the collection of data in the Case Report Form and manage the extraction and interpretation of data;
- an Administrative Assistant and a linguistic and cultural mediator provide organizational support to the patients enrolled in clinical trials and their families.
In addition, TCTO offers advice and guide on quality related aspects of clinical research, ethical issues and privacy.
Emanuela Ferrigno | Quality assurance
Elena Albertazzi | Data manager
Alessandra Bergami | Clinical Study manager/Regulatory Affair Office
Carmen Caputo | Data manager
Laura Castagnaro | Quality manager
Alessandra Clerici | Data manager
Ambra Corti | Clinical Study manager/Regulatory Affair Office
Marcella Facchini | Clinical Study manager/ Data manager
Claudia Fossati | Data manager
Sara Locatelli | Data Manager/Monitor