Our management team has extensive experience in clinical trials and operations.
George started his career as a statistician at Burroughs Welcome and went on to co-found a successful statistical consulting and data management company that was acquired. During his career he has worked with hundreds of clients and helped obtain approval for numerous products from a broad range of therapeutic areas. George has represented clients in numerous FDA meetings and panel meetings. He has served as the lead statistician or team leader on numerous products that were cleared or approved in all areas of the FDA (PMAs, 510(k)s, NDAs, and BLAs). His broad range of statistical analysis experience includes DMC/DSMBs, analysis planning, interim analyses, adaptive trials, and other areas. George has also been the primary author of reporting systems and programming tools to help improve efficiency and appearance of output.
Martha has over 20 years of experience in the healthcare industry with the last 18 years focused in the clinical trial area. Her experience includes management of all aspects of company operations, business development, marketing, finance, budgets, contract management, quality assurance and process improvement. She has served in multiple project roles and is experienced with data and project management. Martha has served as a company Quality Assurance leader and is experienced in implementing a strong quality management system. Her firsthand industry knowledge has been key to helping improve efficiency while ensuring the company consistently meets industry standards. She has managed numerous successful audits. Martha works closely with clients to make sure project needs are met and that quality expectations are delivered.
Jeff has over two decades of diverse business experience as a successful entrepreneur from startup to acquisition. He has worked as a senior executive in clinical trials for pharmaceutical, biotechnology, and med-tech companies seeking to develop their assets into safe and effective treatment options. His experience includes multiple leadership roles in business development, branding, marketing, corporate communications and strategic planning activities. Jeff has a wide appreciation of the complexities associated with getting a drug, or device to market. From fundraising and building a team of KOLs, to navigating the regulatory landscape, Jeff works with companies at various stages during their product development and seeks to find best fit solutions for their current and future stages of development. He identifies and approaches the unique needs of each client differently maximizing the value of the Stat One platform to the client. His knowledge of data management, programming, and statistical consulting is helpful in assessing client needs as he realizes the importance of responsiveness, flexibility and a quality system to deliver an efficient and affordable service.