🦋Ep. 13: The New Normal: Clinical Trials & Research Update - Chat with Edye Edens, JD, MA, CIP, CCRP

The FINAL episode - since we're over in the clinical side of the house, we wanted to reach out to a NEW TO THE SHOW guest, Edye Edens, to find out how clinical research has been rolling during #COVID19. Bio: Joining First Class Solutions, Inc. in 2017, Edye T. Edens serves as Senior Research Compliance Consultant focusing on research compliance and life sciences. Edye is a licensed attorney with an international human rights, ethics, and health law background. Her legal consulting services include, but are not limited to, research administration, healthcare compliance, grants/contracts to IRB, COI, education, privacy, HIPAA, FDA, AAHRPP, misconduct and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology). Services provided include education and training, program creation and management, organizational change management, or even as a complete outsourcing solution. Additionally, Ms. Edens regularly publishes articles and speaks at regional and national professional research and compliance association meetings, including HCCA, SCCE, PRIM&R, MAGI, AAHRPP, SPARC, RAPS, and AHLA. Previously, while in-house for a decade at Indiana University, she focused on the role of human rights in health and worked at the Human Subject Offices on both the Bloomington and Indianapolis campuses, the Indianapolis Grant Services office, Clinical Research Compliance Office and the Research Integrity Office aiding in quality assurance and compliance matters including managing accreditations, internal auditing, education and managing consultation projects involving outside entities. In 2016, she became the first Quality and Compliance Manager for the IU Simon Cancer Center over all aspects of compliance related to all clinical trials performed at IUSCC, before departing for the consulting world. Educationally, she completed her MA in International Research Ethics in 2012, and was the program manager for a NIH grant to aid in creating a joint international institutional review board (IRB) in conjunction with IU’s existing Moi University medical school partnership in Kenya and the IU Center for Bioethics, which expanded her ability to consult in compliance matters globally. She is also a Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), and holds a green belt certification in Lean Six Sigma. Additionally, she teaches at IU’s McKinney School of Law and Fairbanks School  of Public Health in Indianapolis, and oversees the Hall Center for Law and Health’s Externship Program. BTW - here's my interview with Edye on The Point Podcast at Apex Benefits - about COVID-19 Vaccine development: https://www.youtube.com/watch?v=gaVPi9DQwrA Thanks to ALL #TheNewNormal guests for the month of April!