Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
Rapid growth in gene therapy is expected to receive additional support as the Food...
FEATURED E-BOOK
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical...
Understanding Various Site Use Cases for eSource and EDC
Sites can improve data capture, management, and compliance using a site-centric eSource or EDC...
Device Risk Determinations for IVD Research
Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food...
Successful OnCore Implementation: Lessons from Blended Learning and Workforce Training
Implementing OnCore with a phased and blended learning approach at a large institution showed...
Reporting Unexpected Incidents to the IBC
When unexpected events occur during the conduct of a clinical trial, research personnel may...
New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs...
Phases of Clinical Research: A Detailed Overview
Each clinical trial phase builds on the last, from initial safety to post-market studies,...
Ace Your Next FDA Inspection
Adhering to FDA guidelines is crucial for sponsors and sites to ensure successful inspections,...
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