Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry,
Reviews
Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate
HRPP staffing is essential for maintaining research ethics, even with sIRB mandates streamlining review processes for multisite studies. Discover key HRPP roles and benefits.
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.
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
sIRB 101: An Introduction to Relying on an External IRB
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Device Risk Determinations for IVD Research
Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device
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,
Phases of Clinical Research: A Detailed Overview
Each clinical trial phase builds on the last, from initial safety to post-market studies, ensuring treatments are safe, effective, and beneficial for patients.