What is a Data Monitoring Committee?
DMCs play a vital role in clinical trials by independently reviewing interim data for safety and effectiveness, ensuring participant protection throughout the study.
Research Operations
GxP Best Practices for Safer, Smarter, Faster Clinical Research
GxP guidelines help clinical research meet rigorous standards for safety, quality, and compliance, supporting the development of therapies and medical devices.
Beginner’s Guide to Human Research Protection Programs
Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and welfare of research participants. A
Optimizing Your Human Research Protection Program: The Role of Quality Training
As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is
What is an sIRB and Why Does my Study Need One?
Single IRB (sIRB) review streamlines oversight for multisite trials, reducing administrative burdens while ensuring participant protections across all sites.
Public Perceptions of Clinical Trials: A Comprehensive Survey
The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight
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 and Drug Administration (FDA) Center for
Understanding Various Site Use Cases for eSource and EDC
Sites can improve data capture, management, and compliance using a site-centric eSource or EDC platform, supporting smoother workflows, remote monitoring, and efficient data analysis.
Reporting Unexpected Incidents to the IBC
When unexpected events occur during the conduct of a clinical trial, research personnel may wonder if the event is reportable,
New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible
What Are the Phases of Clinical Trials?
Each clinical trial phase builds on the last, from initial safety to post-market studies, ensuring treatments are safe, effective, and beneficial for patients.
Ace Your Next FDA Inspection
Adhering to FDA guidelines is crucial for sponsors and sites to ensure successful inspections, enabling product approvals and faster market access.