Associate Director, Quality Improvement Office
Neala Lane has been involved with clinical research in academic medical center settings for nearly 20 years. In that time, she’s gained experience in study coordination, regulatory submissions and inspections, study monitoring and auditing, and research compliance administration. Currently, Neala oversees the Quality Improvement Office (QIO) at Indiana University. In this role, she is primarily responsible for the institution's post-approval monitoring and auditing program and for managing all FDA inspections of the institution's clinical investigators. She also helps to oversee the institution's ClinicalTrials.gov compliance program and is regularly involved in research education efforts targeting study coordinators, PIs, and sponsor-investigators (IND/IDE holders).
Purpose Driven Inspection Preparedness: People, Process and Technology — Critical Components to Success