Education
1994 MSN University of Virginia
1998 FNP University of Virginia
The Epsilon Group Responsibilities
Gail Kongable, MSN, FNP is the Vice President of Research and Development
at The Epsilon Group. Her area of specialty is clinical trial coordination.
She oversees the data integrity procedures of surveys, project management,
clinical trials, and results reporting.
Research Experience
Ms. Kongable has over 25 years experience in the coordination and
conduct of clinical trials. This research includes randomized, controlled
trials, survey and epidemiological studies, and phase II, III, and
IV studies. She has coordinated multi-center, international and
national studies with more than 50 participating centers and managed
data for studies involving with over 15,000 patients. Ms. Kongable
has extensive knowledge of the NIH and FDA agencies, GCP guidelines,
regulatory and international harmonization guidelines, as well as
data management, trial coordination and industry standards. She
has been affiliated with the University of Iowa Department of Neurological
Surgery and presently is jointly appointed as Associate Professor
in the Departments of Neurological Surgery and Neurology at the
University of Virginia. She also currently sits on the study review
committee at the National Institute of Health for neurological diseases,
stroke and trauma.
Clinical Experience
Ms. Kongable has extensive experience in critical care, emergency
care and primary care of patients with cardiac and neurological
disorders. In addition, she has concentrated experience with geriatric
and oncology patients, and those with chronic diseases, especially
kidney disease. She currently maintains a primary care practice.
Publications
Ms. Kongable has been a primary or contributing author for publications
in refereed journals reporting trial results, description of methodologies
and conduct of research trial management, as well as integrated
Safety & Efficacy Reports to the National Institute of Health
and the Food and Drug Administration. She has authored and co-authored
chapters for academic textbooks for nurses and allied health care
workers. In addition, she has served as invited speaker at national
and international symposia and conferences for neurological disease
specialists and the pharmaceutical industry. She has been published
in The Journal of Neurosurgery, Stroke, Critical Care Medicine,
Archives of Neurology and The New England Journal of Medicine.
Michelle Schlesinger, CPA
Senior Accountant
Education
1998 BS Commerce University of Virginia
CPA Certification
2000 Commonwealth of Virginia
2001 State of Colorado
The Epsilon Group Responsibilities
Michelle Schlesinger, CPA is the Senior Accountant at The Epsilon Group. She oversees the daily financial operations of The Epsilon Group. She has experience in the Medical Device Approval Process, including the preparation of 513(g) and 510(k) submissions to the Food and Drug Administration.
Experience
Ms. Schlesinger worked for 3 years as a Senior Accountant with PricewaterhouseCoopers, LLC (PwC) in Washington, D.C. and Denver, Colorado. She focused primarily on the technology sector and was involved in several Initial and Secondary Public Offerings. After leaving PwC, she served for 4 years as the Controller of Frasier Meadows Retirement Community, a Continuing Care Retirement Community located in Boulder, Colorado.