In 1985, the group of Biometrics was established within the SSFA (Società di Scienze Farmacologiche Applicate), aimed to create a framework to address issues related to statistical methodology in clinical and pre-clinical trials. Afterwards, the group was named BIAS (Biometristi dell’Industria ASsociati), a formal statute and a coordinating committee were established and the group became a point of reference for anyone involved in the statistical analysis and data management in the pharmaceutical sector in Italy. BIAS comprises Statisticians and Data Managers employed in pharmaceutical companies, CROs, universities and research institutes.
The main purposes of BIAS are the following:
• To exchange information and promote collaboration among the members of the group on issues related to the profession of statistician and data manager in the Italian pharmaceutical sector.
• To promote and maintain continuous education and professional growth.
• To update the standards within statistics and data management according to the changing needs of the pharmaceutical industry, regulations and guidelines (e.g., GxP and CDISC).
• To instruct non-statistical personnel to understand and evaluate statistical and data management features relevant to clinical research.
• To encourage the collaboration and knowledge exchange with other groups of professionals (e.g., SSFA, EFSPI and SISMEC).
• To interact with regulatory organizations (e.g., Italian Ministry of Health, AIFA and EMA) on statistics and data management issues.
Currently, BIAS has nearly 200 members and it organizes at least one seminar and one national conference per year.View website