Joining First Class Solutions, Inc. in 2017, Edye T. Edens
serves as our Senior Research Compliance Consultant
focusing on research compliance and life sciences. Edye
is a licensed attorney with an international human rights,
research ethics, and health law background.
Her consulting services include research administration,
healthcare compliance, grants/contracts to IRB, COI, education, privacy, HIPAA,
multiple areas of FDA compliance related to drugs, devices, and food; 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, 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. 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 in
Indianapolis, and oversees the Hall Center for Law and Health’s Externship
Program.