About Us

John Brega

Standards Implementation & Integrated Safety Consultant

John Brega has been a leader in clinical research operations since 1987. He has been involved in 17 FDA submissions, managed 14 Integrated Safety database projects, and played a key role in the design and implementation of statistical computing environments for 15 pharmaceutical companies. He founded Resource Biometrics, a CRO which he managed for 6 years until its acquisition in 1996. Since 2004 he has consulted with 12 companies on the implementation of CDISC standards for both internal operations and regulatory submissions. In 2005 he founded the Bay Area CDISC Implementation Network, the first CDISC user group.

Mr. Brega's areas of special expertise include CDISC data conversions, integrated safety, management of outsourcing projects, design and implementation of statistical computing environments, SOP development, software implementation, validation, and Part 11 compliance.