Peter is a seasoned Life Science consultant with 20+ years’ experience specializing in business transformation by leveraging industry knowledge and consulting expertise to develop deep business value and driving best-in-class Regulatory and Clinical solutions.  Peter has been the lead on several projects, including Business Architecture, Business Analysis, Program and Project Management to companies such as Pfizer, Eisai, Merck, and BMS in the areas of Regulatory Operations, Clinical Operations and Pharmacovigilance.  Peter recently led a multi-year, global regulatory business transformation to redefine business processes and establish a single regulatory information technology (RIMS) as an authoritative source of regulatory information and to improve the management of the key enterprise assets.

INFORMATION SYSTEMS EXPERTISE: Regulatory Information Management System (RIMS) | Electronic Common Technical Document (eCTD) | Electronic Trial Master File (eTMF) | Electronic Document Management System (eDMS) | Electronic Data Capture (EDC) Clinical Data Repositories | Clinical Systems Integration | 21 CFR Part 11| Clinical Master Data Management | Clinical Data & Operational Analytics | Clinical Data Governance | CDISC | SDLC | Veeva Vault RIM