Our Staff

Gail Kongable, MSN, FNP, RN
Vice President of Research & Development

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.

 

 

"We uncover the evidence for evidence-based medicine"