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| Ellen R. Esterline, M.A. Ellen specializes in helping medical device start-ups face challenging compliance issues for both US and international Quality Systems. She has extensive experience in organizational development and leadership training. Her published work includes articles, books, and training courses. She also writes operations manuals, quality systems, and procedures. Ellen has worked with diverse clients, including process industry manufacturers, nonprofit organizations, and medical device manufacturers. She has assisted manufacturers of implantable Class II and Class III devices in setting up quality systems to comply with requirements of the US FDA Quality System Regulations, ISO 9001, and the CE Mark. Her professional memberships include the Association for the Advancement of Medical Instrumentation (AAMI) and the Regulatory Affairs Professionals Society (RAPS). Christine L. Peterson, B.A. Christine is PaxMed International's lead clinical trials manager. With overall responsibility for both administrative management and monitoring of a project, Christine is involved in the initial design of the study and forms, coordination of investigator and staff training, preparation of regular progress reports, and liaison between study-site personnel and sponsors. She maintains the integrity of your study through careful management and a conscientious focus on your unique scientific and regulatory goals for the trial. Christine has initiated and implemented a real-time monitoring system for clinical trials that emphasizes a close, ongoing relationship between the research site and the monitor. Deborah A. Moyer, R.N., B.S.N. Deborah is PaxMed's lead data manager and a clinical research monitor. She is responsible for clinical site liaison for specific trials and has overall responsibility for PaxMed's clinical trial database development, implementation and data management. She specializes in the design of training material, and in conducting trainings for investigators, study site coordinators, and other professional staff. Her data management responsibilities include coordinating the design and development of custom study-specific database systems, managing the data entry and reporting process, and preparing data for statistical analysis. Linda K. Schulz, R.D.H., B.S.D.H. Linda is a clinical research monitor with special expertise in dental studies and radiographic interpretation. She has more than 10 years of hands-on clinical experience and a broad background in patient care. Linda has implemented a system for accurate measurement of vertical bone loss around dental implants through digital analysis. Linda also coordinates data queries to study centers and ensures that data are reliable and accurate before entry into PaxMed International study databases. Paul Smith, M.B.A. Paul is PaxMed's financial Controller, and contributes to strategic planning and project management. He will help ensure that your project is on track and responsive to your financial realities. |
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