The Company

Istituto Superiore Di Sanità (ISS) is a public institute, as the technical-scientific body of the National Health Service in Italy, carries out research, experimentation, control, consultancy, documentation and training in public health matters

 

The Challenge

Development of an eCRF web platform for the management of the PITER-HCV observational study involving more than 100 clinical centers, with a target of 10,000 patients enrolled. The PITER-HCV cohort study aims to assess the long-term impact of new DAAs, in particular on their effectiveness in clinical practice and provides for a multicentric collection of epidemiological, clinical and HCV infection data and coinfections from HBV and HIV, conducted in different periods of recruitment.

 

The solution

Development of eCRF web platform based on the OpenClinica system, in compliance with the international standards for the collection and management of clinical data, for the management of the study on Viral Hepatitis Therapy (PITER). The web platform allows the collection of epidemiological, clinical and treatment data of HCV infections and of HBV and HIV coinfections by the centers involved in the experimentation.

 

Results

  • unified study management and multicentric collection of epidemiological, clinical and infection therapy data
  • real-time monitoring of study progress and patient data collected