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,
IRB
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.
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
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
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
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.
4 Unique Challenges of Oncology Trials
Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address complex study demands and precision needs.
IBC vs. IRB: What’s the Difference?
Gene therapy research requires both IRB and IBC oversight—while IRBs protect participants, IBCs ensure community and environmental safety with local site-specific reviews.
Data Safety Monitoring Boards Facilitate Ethical Research
In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Find out what researchers should consider in selecting and using these technologies and how to adequately inform participants of the potential risks.
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and