Roles and Responsibilities

Michael Shanler covers industry technologies used by manufacturers, with a specific focus on scientific R&D, product innovation, collaboration, laboratory operations and informatics. His vertical life science coverage specifically includes drug discovery, clinical development, regulatory submission, document management, compliance and related technologies for pharmaceuticals, biotechnology, contract research organizations (CROs), medical device manufacturers, and contract manufacturing organizations (CMOs). R&D is a broad category and spans the nonregulated and regulated (e.g., GxP) space. "Research" (e.g., drug discovery) inquiries generally cover molecular modeling, laboratory informatics, laboratory automation, logistics and scientific informatics (bioinformatics, cheminformatics and so forth). "Development" topics (e.g., clinical development) include trends and vendor positioning for e-clinical systems, electronic data capture (EDC), clinical trial management system (CTMS), electronic trial master file (eTMF), regulatory information management systems (RIMS), ECM, electronic core technical document (eCTD), e-submission systems, pharmacovigilance (PV) and safety, and regulatory intelligence. His coverage for laboratory informatics spans all R&D and manufacturing. This includes electronic laboratory notebook (ELN), laboratory information management system (LIMS), laboratory execution system (LES) and scientific data management systems (SDMS).