AbaNovus srl C.so Orazio Raimondo 18038 SANREMO - Italy info@AbaNovus.com Maurizio Rainisio Maurizio.Rainisio@AbaNovus.com Tel. +39 335301877 |
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. 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.
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.
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.
He has successfully led very cohesive teams of statisticians, programmers
and data managers, who have always delivered proven outstanding performance. |