Susan Bairnsfather, CEO
has over 19 years of pharmaceutical industry experience. She began working as a regulatory affairs professional/regulatory writer, then as a statistical programmer, and later returned to work as a regulatory writer. She established her own company, EPharmaTech, in 2006. Consultant services are provided as a regulatory writer, content management developer, and statistical analyst. Susan has broad experience in writing the full range of preclinical and clinical regulatory documents, including submissions for the US, Canadian, and EU regulatory agencies. She is also experienced in data analyses, along with electronically integrating data and documentation to the eCTD. She has additionally participated in CDISC and in HL7 SPL initiatives, and has been an active presenter and workshop leader for American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), Drug Information Association (DIA), and the Pharmaceutical SAS Users Group (PSUG).
Lee Bairnsfather, PhD
has over 30 years experience in the health sciences as a biostatistician, researcher, professor, department chair, and chief information officer. He currently serves as the Director of Research and Biostatistics at EPharmaTech. Before joining EPharmaTech, he pursued a career at LSU Health Sciences Center, where he began as Assistant Professor in the Department of Physiology and Biophysics and conducted cardiovascular research on models of cardiac ischemia. As Professor of Biometry, he conducted cardiac and bioinformatics research and taught biostatistics, physiology,and electronics instrumentation. During this time, he also served as Chairman of the Department of Bioinformatics and Computational Biology and authored/co-authored over 100 publications in health sciences research. From 2008 to 2012, he was the Assistant Vice President for Information Technology for the LSU System and also served as Chief Information Officer for LSU Health. In this role, he managed the installation and onsite startups of the electronic health record system for 10 hospitals under the LSU organization.
..Designed by Susan Bairnsfather
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