Founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. He has a degree in microbiology/infectious disease. Steve worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the areas of clinical research for all study phases, as well as pre-clinical activities.
Steve has extensive field experience as a CRA and as a CQA auditor, He has expertise in Clinical Operations, including the functions of clinical monitoring, program management, product development, CQA, and inspectional operations. He has recently retired from Pharma where he was Sr Manager, Global Clinical Operations. His current activities as a consultant include CQA inspections and training, Gap Analysis Audits, and Clinical Project Oversight.
Steve has served on an IRB and has served as PI on several phase four studies. He has published a monthly international clinical trial conduct newsletter (2000-2008) and has been a frequent presenter of webinars, and seminars over a broad range of topics for FDA News and Thompson Publishing and Bioforum. GCP, Regulatory, and CQA training of academia, government (US and Canada), and pharma staff have been a large part of his activities since 1994.
His many years of experience and expertise and his interactive presentations enable participant interaction and exchange of information/options.