Gateway to Compliance: Creating a Business Case for eRegulatory
Presented by: Leslie Korbee, BS, SI (ASCP), CCRA with Academic Regulatory & Monitoring Services, LLC
This webinar addresses the business and compliance case for moving to an eRegulatory solution for clinical research documentation. If you are uncertain if your institution or your team can afford to implement eRegulatory, this webinar is designed to support your decision making process. The presenter, Leslie Korbee, CCRA has experience with developing and implementing an eRegulatory process with more than 300 clinical research professionals at Cincinnati Children’s, the # 2 pediatric institution in the USA. She has also recently consulted with another academic medical institution on the implementation of the Complion eRegulatory system.
- Understand the background and overview of eRegulatory systems
- Be able to navigate the basics of getting started with eRegulatory
- Have the tools and resources needed to create a business case for eRegulatory
About the Presenter
Leslie Korbee, BS, SI (ASCP), CCRA with Academic Regulatory & Monitoring Services, LLC
Leslie Korbee brings more than 20 years of clinical trials experience to her work in clinical research. Korbee has served in clinical trial development, and as a regulatory writer, and safety monitor, and as a co-author on multiple publications including two New England Journal of Medicine manuscripts. She was one the lead developers of an eRegulatory system supporting clinical research at Cincinnati Children’s since 2015. Her clinical research experience includes project management and regulatory oversight of the award winning multi-center international study, the MILES Trial, working with Frank McCormack, MD. This trial resulted in the FDA approval of sirolimus as the first ever approved treatment for the previously fatal rare lung disease lymphangioleiomyomatosis (LAM). She continues to serve the LAM community as a study monitor for other LAM trials. In addition to her work in LAM clinical research, she has also served for the past ten years with Dr. Bruce Trapnell in clinical research in pulmonary alveolar proteinosis (PAP), another rare lung disease with few treatment options, and continues to support that research. Korbee has also had a strong history of success as a grant writer, supporting investigators in the development of more than 30 million dollars in grants awarded to Cincinnati Children’s Hospital Medical Center during the past ten years.
After her retirement from Cincinnati Children’s, Leslie began a consulting practice, Academic Regulatory & Monitoring Services, LLC to support investigator initiated clinical research. She routinely consults with multiple institutions in Cincinnati, Ohio. Korbee’s training includes a BS from the University of Cincinnati, with a biology major and a chemistry minor. Through her 10-year clinical laboratory background, she became a registered specialist in Immunology, and after moving away from the clinical laboratory, she was credentialed as a Certified Clinical Research Associate through ACRP. She is very grateful for the opportunity to serve the clinical research and academic medical research community.