George Stoms, President
Informed by more than 25 years experience in pharmaceutical and device development, George Stoms leads Vital Systems to provide clients with a suite of focused services and attentive staff. Vital Systems has assisted clients with clinical operations, monitoring, data management and statistical analysis, medical writing, technology solutions, and quality assurance audits or process reviews.
With experience ranging from SAS programming to strategic planning for global regulatory submissions and post-marketing surveillance, both "detailed" and "big picture" perspectives are brought to a client's situation. Versed in FDA and ICH guidelines, projects have included EU, Chinese, and Japanese regulatory submissions. At the request of the Uppsala Monitoring Center, Mr. Stoms has represented the makers of the WHO Drug Dictionary at the North American Users Group since 2005, training large and small pharmaceutical companies, CROs, and consultants for medication/drug coding.
Under his direction, Vital Systems demands the highest of standards, and values open communications. Deadlines and deliverables are high priorities and what is promised is provided. Repeat clients are common, and successful relationships continue to thrive as ongoing partnerships.
Jennifer Powell, RN, BSN, Vice President & Director of Project Management
Mrs. Powell, a registered nurse, has worked as a clinical research associate and a project manager throughout her career. She graduated in 2000 with her Bachelor of Science in Nursing from Thomas Jefferson University in Pennsylvania. Mrs. Powell has extensive experience with Phase I, II and III trials as well as device studies. Her indication experience ranges from Infertility, Infectious Disease, Hematology, Neurology, Dermatology, Psychology, Nephrology and Oncology.
Mrs. Powell pioneered two EMT-B courses at a United States Army Medic base in Italy as well as two courses for the United States Navy in Italy. As a first responder instructor she instructed students in human anatomy and physiology principles. Mrs. Powell's attention to details and instructor abilities has lead to the education of many qualified clinical research associates.
Alex Yaroshinsky, PhD, Biostatistician
Dr. Yaroshinsky is a Senior Biostatistician with 23 years of experience in biotechnology industry, with a focus on cancer/heart failure/gene therapy areas. With expertise in biostatistics, clinical development, and regulatory issues, Alex has extensive experience working with FDA and European Medicinal Agency (EMA). The primary interests include analysis methods based on recurrent clinical events correlated with risk of death. Another area of interest is the statistical design of clinical trials with small sample sizes for early efficacy evaluation. Alex held management and consulting positions at Harvard School of Public Health, Roche, Boots Pharmaceuticals, Revance Therapeutics, Connetics, Celladon, and other pharmaceutical and biotechnology companies, consulted extensively for venture capital groups such as ProQuest Investments and Enterprise Partners Venture Capital.