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Jim Saunders

“I am passionate about the architecture and creation of enterprise IT platforms that produce exceptional user experiences and business efficiencies.”

Jim uses his vast experience designing and developing robust IT platforms for entrepreneurial companies to create systems that assist clients across all phases of Advisory Committee preparation. He specializes in translating all facets of business operations into systems that integrate data and user experiences into seamless, easy-to-use platforms.

Approach

Jim’s approach to system architecture and design is based on the belief that IT platforms should create efficiencies and support users in being the best they can be in an operational area, and that an IT system should never be a hindrance to getting things done, regardless of the computer literacy of the user.

Background

Jim has been a founding member of pharmaceutical service and clinical research companies, with more than 25 years of experience in the clinical research field. He has guided startups and Fortune 100 companies in all phases of clinical studies, directing the design and implementation of data-collection technology systems, as well as implementing risk evaluation and mitigation strategies and large postmarket safety studies. He has extensive knowledge in regulatory compliance technology, including HIPAA/HITECH, 21 CFR Part 11, Sunshine Act, and Sarbox. As a strategic-technology architect, Jim has designed and developed a variety of systems to manage pharmaceutical sales operations and post-approval regulatory compliance. He holds a degree in computer science from North Carolina State University.

Special Interests

Jim is a founding member of 3D’s nonprofit Get Stuff Done 4 Kids. In his spare time, he likes to spend time with his family, exercise, golf, and go offshore fishing.