Lorraine D. Ellis founded Research Dynamics in 1993 to provide specialty clinical research services to the industry. Her expertise and experience in pharmaceutical product development has become the foundation of the business.
During her 30 years experience in the pharmaceutical industry, she has worked in positions throughout the product development pathway from pre-clinical laboratories through Clinical Operations to Project Management. She has worked at several pharmaceutical companies in positions ranging from Associate Pharmacologist to Director, Medical Project Planning and Development. During her work in clinical operations, she has completed various clinical trial activities from protocol design and preparation, through monitoring to preparing FDA submissions. While she was Director, Clinical Operations, Ms. Ellis developed efficient work flow procedures and CTMS technology to integrate technology into the work flow for greater efficiency.
For the past 20 years she has developed and taught clinical research training programs to insure project quality and compliance to FDA/ICH standards to all types of professionals from monitors to CEOs and from Coordinators to Investigators.. Realizing the impact technology can have on clinical trial methods, she was part of the team that designed and implemented one of the first CTMS systems over 15 years ago and it is still being used by dozens of companies. She continues to be an advisor to technology companies for clinical research systems.
Ms. Ellis has a BA (Biology) from Hofstra University, MS (Biology) from Adelphi University, and MBA from Rochester Institute of Technology. Having completed a minor in secondary education, she used the expertise to design and provide training programs. Continuing her work in education she is an Adjunct Professor at RIT and on the RIT Clinical Advisory Board to develop a new Masters Degree in Clinical Research Management. She is also an Adjunct Assistant Professor for MGH IHP Graduate Program in Clinical Investigation.
She is active in professional organizations: Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP), and Women President Organization (WPO). Her organizational volunteer work includes serving on several committees and advisory boards. She was a member of the ACRP board of directors for 5 years.