David R. McCarthy, Jr.
President and Chief Executive Officer
Dave McCarthy serves as President and Chief Executive Officer. In this role he leads and executes the strategy of eStudySite, and has been involved with the Company as an Operating Executive and Director for over 10 years. Dave has diverse experience in healthcare, including the development of multiple technology and clinical provider companies spanning medical training and patient engagement systems, outpatient surgery and clinical trials. Working at Bain & Company, he was involved in the early development of the firm’s healthcare/hospital practice. He has advised multiple institutional investors in the development and execution of investment strategies in healthcare. Dave has additionally spent a number of years as an entrepreneur in the software and technology business. Dave received his undergraduate degree from Princeton University, and has a Masters of Business Administration from Stanford University.
Valerie Horne, Ph. D.
Senior Vice President of Operations
Valerie Horne oversees business and clinical operations at eStudySite. She started with eStudySite in 2008 and has worn many hats from negotiating budgets and contracts with sponsors and 3rd party vendors, project managing study start up across all sites, recruitment planning and implementation, starting up new sites from the ground up as well as business development and regulatory oversight. She now is responsible for the overall quality and efficiency across our sites as well as regulatory, trial execution, budgets, contracts, and recruitment. Valerie received her B.S. degree in Chemistry from MIT and her Ph.D. in Cell Biology from UCSD.
Vice President of Finance
Lew Schwartz began managing Accounting & Finance as the Corporate Controller for eStudySite in February 2007, bringing with him 14 years of small business accounting experience. Raised in San Diego, Lew earned degrees from the University of Washington in Seattle concentrating in Accounting and Economics. He has done accounting in a variety of industries from professional baseball and soccer to commercial.
Senior Vice President of Commercial Operations
Daniel Robitaille is the Vice President of Commercial Operations. He first joined eStudySite in 2009 in a Business Development position and has had various roles in the organization over the years. Prior to joining, Dan established himself at California Clinical Trials (now PAREXEL) as a CRC and Site Manager of one of their successful in-patient CNS clinics and later as a Director of Business Development at Syneos Health (Previously INC Research). Dan brought with him a breadth of experience in client relations, project leadership, operational management, and early/late phase clinical trial management.
Director of Trial Execution
Ruth has been in the clinical research field since 1996, originally working as a coordinator in Dermatology and Neurology. She joined the eStudySite team over 12 years ago, starting as a coordinator and site director and then began supporting our sites by leading our recruitment and outreach efforts. She was instrumental in building a full time recruitment department within our organization. While continuing to manage study recruitment and enrollment, she is now responsible for managing study start up timelines from Study Award to First patient In.
Director of Business and Operational Analytics
In her time at eStudySite, Jamie has served in several roles, from study coordinator to site director to most recently assisting in the implementation of eSource company-wide. Now focused on providing data driven solutions, she works closely with finance and clinical operations teams to optimize operational and business efficiency. Jamie also leads budget and contract negotiations with industry partners and third-party vendors. Jamie earned her B.S. in Health Management from the University of Minnesota, Crookston.
Pat Kappen is one of the founders of eStudySite, joining Dr. O’Riordan in conducting medical research in 1995 prior to incorporating eStudySite in 1999. She earned her Certified Clinical Research Professional designation from SoCRA in 2005 and a Professional Certificate in Clinical Trials Design & Management from UCSD extension in 2007. At the beginning when the company was very small, she took care of almost everything pertaining to the studies except coordinating duties. This included handling regulatory documentation with sponsors, managing the regulatory binders, processing IRB submissions including reworking sponsor consents to conform to the local IRB requirements, contracts, lab specimen shipping, subject scheduling, follow up visits, and FDA audits. With the growth of the company, she continues to be responsible for study regulatory documentation, all submissions to sponsors/CROs, submissions to IRBs, processing IRB approvals, and maintaining investigators’ CVs and clinical trial lists. Pat is focused on excellent customer service and exceeding timeline expectations for submissions and approvals.
Director of Quality Assurance
Bernadette Wilson is the Director of Quality Assurance. With over 19 years of Clinical Trial experience, she has a broad knowledge of clinical processes and procedures, electronic documentation systems, Good Clinical Practices, FDA Regulations and industry standards. She started with eStudySite in 2012 and is instrumental in providing quality data by performing extensive quality assurance review of study documents and data across a variety of complex studies of different therapeutic areas and phases for multiple sites. She also leads SOP development, develops and conducts training, and helps develop processes to improve overall quality and continuity across sites. Bernadette is responsible for supporting all FDA Inspections and Sponsor audits with an outstanding record.