Management Team Roberta Hines, President & CEO Roberta has over 28 years of experience as a successful, senior level regulatory professional in the medical device industry. Her expertise is highly regarded by leaders in the design and development of medical devices.  She brings a unique blend of expertise in the regulatory affairs, quality assurance and clinical research in Class II/III devices including: implantable cardiovascular and orthopedic devices, interventional cardiology and endovascular devices, combination drug/device products, non-invasive monitors and various ancillary accessories and equipment including software and hardware driven devices. She has long-term relationships with regulatory agencies and Notified Bodies around the world.  With her experience in strategic regulatory and clinical research planning, she guides our clients in bringing their products from concept through global market introduction in the fastest time possible.   Marlys Chellew, Clinical Partner NCRG has partnered with Marlys Chellew, BSN, MBA. Marlys is the founding President and CEO of Chellew Clinical Outsourcing (CCO). Marlys has over 15 years of clinical research experience in the medical device industry and 7 years experience as a critical care RN. Her experience in conducting over 75 clinical studies ranges from user preference to FIM to CE Mark to PMA studies, in geographies all over the world. Her areas of expertise include cardiovascular intervention and surgery, peripheral intervention and surgery, diabetes (pediatrics, combination products), and obesity. Specializing in study design/development and clinical operations, she effectively recruits and manages small and large teams of clinical research professionals to meet clients' business objectives in a timely and cost effective manner. Through CCO, NCRG is able to recruit highly skilled, motivated and productive clinical consultants. Teamwork, communication and experienced project management come together to produce high quality, efficient and professional results through this partnership. Efficiency, quality and execution are key customer focus points for NCRG and CCO.		Management Team NCRG utilizes Innoventz for Data Management.  Osman Qamar is the founder and president of Innoventz Corporation. Osman earned his Master's Degree in Biomedical Engineering from the University of Southern California (USC). Early in his career, Osman acquired invaluable experience working as a consultant for medical device technology companies. Through this experience, he soon perceived the informational gaps and bottlenecks that often exist between various levels of management, production teams, and communication networks. Osman was able to deliver such unique IP to medical data that he advanced to the level of independent consult and eventually became a clinical data entrepreneur. Innoventz continues to exemplify Osman's vision for the future of clinical data management. Dedicated to the highest levels of integrity and standards of excellence, Osman is directly involved in the recruiting and development of his management staff and team members.   Functional Areas of Expertise  Risk Assessment  Strategic Planning  Org. Development  Staff Recruitment/Training  Budgeting/P & L Control  Forecasting    High-Level Systems Design  Systems Integration  Clinical Research Systems  Medical Device Data Tools  Data Team Development  Advanced Databases    Project-Level Consulting  Lead Data Programming  Cross-Functional Solutions  Data Tool Invention  Quality Assurance  Evaluation and Correction      Regulatory Specialists and Contracted Expertise NCRG employs regulatory specialists and administrative personnel to support clinical trials and submissions.  In addition to internal expertise, NCRG employs several contracted personnel around the world to monitor studies, for data management, for statistical analyses and for reporting of clinical trial results.  Our contracted suppliers are highly experienced in First in Man, CE Mark studies, and US IDE studies specializing in cardiovascular, endovascular, neurovascular, and orthopedic devices.