Scope of Things

Discussing Review Boards, Social Media, and World Events With Donna Dorozinsky

February 6, 2023


In this episode of The Scope of Things, host Deborah Borfitz provides a rundown of the latest news in the clinical trials field: a massive health research initiative in the UK, widespread overdosing of trial participants, a cholesterol-lowering vaccine, the growing popularity of phage therapy, a novel scoring mechanism for de-risking trials for chronic diseases, a strategy for making staph vaccines a reality, and the latest oral drugs heading to trials that could eliminate one of the chief barriers to insulin therapy for diabetics. Deborah also speaks with Donna Dorozinsky, President & CEO of Just in Time GCP, about recent changes related to expectations of institutional review boards, the use of social media for recruitment and communication purposes, and the impact of world events on clinical data management.

Donna Dorozinsky, President & CEO Just in Time GCP
As the Founder & CEO of Just in Time GCP, Donna is responsible for running all facets of the business.   She is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.  Her vast experiences dealing with small to large Pharma companies, academic centers, regulatory agencies, CROs, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance.  She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations.  In 2005 Donna founded Just in Time GCP.  In her capacity as Founder & CEO, she has built an organization that is highly respected within the clinical compliance and TMF management services industries.  As a consultant, she has led many large projects performing operational gap analysis and implementing process improvement initiatives for sponsors, CROs and clinical sites.  She has extensive experience in inspection readiness/preparation and has assisted organizations in developing and executing remediations across clinical systems, quality management systems, and TMF services.

Donna has presented numerous training programs in topics of GCP compliance, Quality Management Systems, Inspection Readiness, and TMF Management and is a dynamic educator.  She is the Lead Editor in the newest edition of Good Clinical Practice: A Question and Answer Guide, is a member of the TMF Reference Model Steering Committee, and was recently named an Ernst & Young Entrepreneur of the Year.  Under Donn’s leadership, Just in Time GCP has been named to the INC5000 for the past 3 years and was most recently named an INC500 Best Workplace.  Donna earned a BSN from Gwynedd Mercy University where she is currently serving as a member of the Board of Trustees and an MSN from Widener University.