AbaNovus is a Drug Development/Clinical Trials Consulting Organization. Its mission is to provide expertise and services in Drug Development/Clinical Development related functions with special emphasis on Biostatistics, Data Management and Organization. AbaNovus was founded in Italy in 2010 as a privately owned limited liability company.

Maurizio Rainisio is the CEO of AbaNovus, also covering the function of Expert Consultant.

He graduated in Mathematics at the University of Milan. After spending a few years at the Institute of Biometry of the local Faculty of Medicine with a postgraduate grant from Italy’s CNR, in 1978 he joined Ciba-Geigy, first as Project Statistician and later as leader of the newborn Mathematical Statistics group. In 1984 he founded SFR and ASC, privately owned companies providing expertise and services in the field of statistics and clinical data management. With these companies he worked for leading pharmaceutical companies on different projects in a variety of therapeutic areas. From 2000, when Actelion acquired ASC, until 2010 he served as VP, Head of Global Biometry at Actelion. In December 2010 he left Actelion to become CEO and Expert Consultant at AbaNovus.

Maurizio Rainisio has more than thirty years technical and managerial experience in Clinical Development. He has participated from the beginning, and in a leading position, in the extraordinary success story of the first years of Actelion. He has a history of interactions with international HAs at all levels and has a strong international reputation.

 
Maurizio Rainisio’s domains of competence:

Methodology and statistics for clinical studies and surveys

His experience spans through multiple therapeutic areas and includes all phases of clinical development. He has contributed to the planning, development, approval and post marketing of successful projects for methodological and statistical aspects including extensive interactions with health authorities at all levels.

Although only from the side of the sponsoring company, he has extensive experience of Data Monitoring Committees (DMC/DSMB) rationale and operations, including the statistical/data management support services.

 
Clinical Data Management

Innovative clinical data management systems for Hoffmann La Roche and Actelion, which have been in production for very long periods of time, have been implemented under his supervision. He has introduced into EDC the use of the Anoto Digital Pen (a tool that constitutes a step forward in the EDC methodology replacing the cumbersome keyboard data entry by simple –from the user point of view – pen and paper).  He has extended experience in WEB-based Endpoint Assessment Committees (EAC); one of the first implementations having been developed under his supervision in the late 90’s.

 
Management and organization

He has successfully led very cohesive teams of statisticians, programmers and data managers, who have always delivered proven outstanding performance.
He supervised the development of full quality management systems for the functions under his supervision and for their interactions with other clinical development functions.