Phases of Clinical Research: A Detailed Overview
Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.Read more
What is a Data Monitoring Committee?
In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.
GxP Best Practices for Safer, Smarter, Faster Clinical Research
Uncover key regulations and insights regarding GxP in pharmaceuticals, medical devices, and clinical research.
Beginner’s Guide to Human Research Protection Programs
A robust institutional HRPP plan includes a comprehensive compliance framework and experienced staff focused on protecting research participants.
Optimizing Your Human Research Protection Program: The Role of Quality Training
Having a robust human research protection program (HRPP) in place is vital when maintaining compliance and keeping participants safe.
What is an sIRB and Why Does my Study Need One?
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.
Public Perceptions of Clinical Trials: A Comprehensive Survey
In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.
Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
Understanding Various Site Use Cases for eSource and EDC
Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.
Device Risk Determinations for IVD Research
Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.
Reporting Unexpected Incidents to the IBC
Find out which unexpected events you should report to the IBC during a clinical trial, and what to expect from the IBC's review.
New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
Explore insights on new CMS policies & Medicaid's fresh clinical trial policy. Stay updated in a rapidly evolving healthcare landscape.