In 1994, Vital Systems was built to accelerate clinical research services for emerging biotechnology, pharmaceutical and medical device companies. Vital Systems prides itself on high quality and responsive service that delivers intelligence from data to clients, allowing them to achieve their product development goals. VSI offers tailored clinical research solutions from our suite of services, ranging from Project Management, Clinical Monitoring and Site Management, Trial Master File Management, Data Management and Statistics, as well as providing Site and Vendor Auditing and Qualification.
'Vital Systems is committed to extending and improving life by accelerating clinical research services for emerging health, biotechnology, pharmaceutical and medical device technologies'.
Vital Systems drives successful projects through great attention to detail, strategical risk management and agile adaptation to adjustments, which net operational savings. Our professional communication style, ability to meet timelines and unique secure web portal design earned us an excellent reputation with many repeat clients. Customized secure web portals facilitate expeditious data review, large report review across geographic and time zone disparity allowing Vital Systems global adaptability. Vital Systems charter collaboration with IBM Watson Life Science products offers a complete suite of modules, randomization, coding and others, within the EDC.
Confidently entrust Vital Systems with your projects. Our team combines decades of CRO experience and applied technology to reduce frustrations and meet your development goals.
Vital Systems works side by side with our clients using expertise to help meet goals and objectives while being accessible and attentive. VSI team members are easily accessible via phone and email, with flexible schedules, to accommodate our global clients. We utilize a team approach to ensure client expectations are met and exceeded.
The size of our team allows Vital Systems to customize our services to meet the needs of our clients and utilize our high quality staff to facilitate any requests. All of our costs and pricing is up front with detailed itemizations.
We are dedicated clinical trial professionals who are committed to the success of your project. All of our SOPs clearly define our processes and can be adapted to meet the requirements of each client as needed. With our decades of CRO experience, highly experienced staff, and applied technology, we reduce costs and help clients reach their goals on schedule.
Quality of Life - “Service Matters, Because People Matter”
At VSI we believe “Service matters, because people matter”. Our clients are not a number, but a valued member of the extended team. We value our client’s time and budget. Excellent customer service is our standard and if we cannot promise that, we do not take the work.
The objective of our business is to accelerate clinical research services for emerging biotechnology, pharmaceutical, and medical device technologies. We provide high quality and reliable services for our clients, and remain focused on a select number of projects in order to provide customized attention.
Vital Systems was incorporated in 1994 and has served clients from the United States, England, Japan, Germany, Austria, China, Canada, and a growing list of countries. Our Drug projects have ranged from "proof-of-concept", and IND submission through Phase 3 pivotal trials, successful NDA & BLA approvals, and Phase 4 marketing support and safety surveillance. Our Medical Device projects have included statistical modeling and data management for studies supporting PMA and 510K submissions.
George Stoms, President
George Stoms’ expert insights are derived from 30 years of pharmaceutical and device experience. As a leader in bioinformatics, supported by a robust CRO data management and statistical experience, Mr. Stoms founded Vital Systems in 1994. Guided by delivering strategic goals of research programs, he draws from his extensive knowledge of research design, statistical analysis, and data management while leveraging technology solutions. From detailed SAS programming to targeted strategic planning for global regulatory submissions, his unique perspective affords client customization. He focuses on responsive and affordable solutions and services that strategically contribute to client’s reaching their goals.
Mr. Stoms earned his Bachelor of Arts degree, Magna Cum Laude in Psychology with emphasis on Research Design. He also attended Northwestern University, studying Evaluation Research and Statistics. Uppsala Monitoring Center has invited Mr. Stoms to represent the creators of the WHO Drug Dictionary at the North American Users Group, training pharmaceutical professionals in coding strategies.
Jennifer Powell, RN, BSN, Senior Consultant
Jennifer Powell is an accomplished CRO executive leader with more than 15 years’ experience. Her global clinical research projects encompass pharmaceutical and medical device trials. Mrs. Powell’s Bachelor of Science degree in Nursing and a Bachelor of Science degree in Health Science allow her to combine her medical and scientific knowledge and give her the unique ability to understand both the broad and intricate details of clinical research.
Mrs. Powell is a dynamic executive manager with extensive project management experience. Tenured in creating client proposals, cost estimates and work orders, she plays an advising role for overall project budget activities. Her responsibilities include building the Vital Systems team, leading sponsor projects ensuring guidelines and best practices are implored and confidently shepherding qualified clinical staff. She leads team brainstorm sessions to ensure delivery of project execution on time and within budget. Mrs. Powell’s history with quality assurance and site compliance auditor, makes her invaluable to Vital Systems and to our clients.
Alex Yaroshinsky, PhD Senior Biostatistician
Alex Yaroshinsky is a Senior Biostatistician with over 27 years of statistical experience in the biotechnology industry. He is a pioneer of novel efficacy evaluation methodologies for proof of concept clinical studies leading to substantial clinical development (Circulation Research, 2011). As a thought leader in biostatistics, clinical development, and regulatory issues, he has held management and consulting positions at Harvard School of Public Health and global pharmaceutical and biotechnology companies. Dr. Yaroshinsky’s statistical therapeutic areas include cancer, cartilage repair, dermatology, gene therapy, heart failure, HIV and pain management. He is an accomplished biostatistician in analysis methods based on recurrent clinical events correlated with risk of death.
Dr. Yaroshinsky implemented and negotiated with the FDA (US) and EMA (EU) primary efficacy evaluation approach based on the various recurrent event analysis methods; demonstrated substantially greater treatment effect than traditional time to first event analysis – applicable to cancer relapses, heart failure hospitalizations, opportunistic infections, etc. (published in Circulation Research, 2014; J Am College of Cardiology, 2014; Biometrics, 2015; Statistics in Medicine, 2016; book chapter on gene therapy trials, 2016, J Pediatric Neurology, 2017). As an established biostatistician, he has consulted extensively for venture capital groups such as ProQuest Investments and Enterprise Partners Venture Capital. Dr. Yaroshinsky’s decades of experience in statistical design of clinical trials make him an asset to VSI.