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.
Vic Abad, MA
Senior Statistician
Education
1971 BS Mathematics, University of San Francisco
1975 MA Mathematics, University of California, Berkeley
1996 MA Fitness and Human Performance, University of Houston, Clear Lake
The Epsilon Group Responsibilities
Vic Abad is a senior statistician at The Epsilon Group. His area of expertise is the statistical design of healthcare-related studies.
Experience
After completing his mathematical and statistical studies, Mr. Abad worked 14 years for IBM in Houston, Texas, as a requirements analyst, software developer, and project manager. In his first 6 years at IBM, he was part of the contract team developing the requirements and software for the initial flights of NASA’s Space Shuttle. His remaining time at IBM was spent developing software and managing projects for the Advanced Control System, a large software system for monitoring and directing process control operations in refineries, chemical plants, and other large process control industries. After leaving IBM, he worked as a consultant, specializing in software applications in the healthcare field. He moved to Charlottesville, Virginia in 1999 and has worked with The Epsilon Group for 4 years.
Dora Leija, MA
Senior Statistician
Education
1974 BS Mathematics, University of Houston
1996 MA Fitness and Human Performance, University of Houston, Clear Lake
The Epsilon Group Responsibilities
Dora Leija is a senior statistician at The Epsilon Group. Her area of expertise is the statistical design of healthcare-related studies, with a particular interest in developing novel and effective graphical methods for presenting study results.
Experience
Ms. Leija worked 20 years for IBM in Houston, Texas, as a software developer, project manager, and software engineer. Ms. Leija worked in a number of software development projects for the NASA Space Shuttle in Houston, including onboard flight software, flight design software, and ground support software. Her tasks included requirements development, software development, and testing. She then worked in the development of the ground support software for the International Space Station at the NASA-JSC Mission Control Center in Houston as a software engineer, project planner, software development manager, and quality control manager. After leaving IBM, she worked as a consultant, specializing in software applications in the healthcare field. She moved to Charlottesville, Virginia in 1999 and has worked with The Epsilon Group for 4 years.
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.