Research Operations
Data on the go: Mobile Application Considerations for Clinical Trials and Beyond
Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.
Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges
Discover how CTMS streamlines patient recruitment & management for successful clinical trials.
University of Nebraska Medical Center Streamlines Regulatory Management and Accelerates Study Startup with Advarra eReg
Learn how Advarra eReg helps UNMC support remote monitoring and how eReg helped address prevalent challenges in clinical research.
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Discover how to protect participant privacy in mobile-app-based clinical research. Learn about risks and what IRBs need to consider in protocol review.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.
Full Board vs Expedited vs Exempt: Why IRBs do That
A discussion on what IRBs must consider, what might tip the scales for a study that could go either way, and what “expedited review” means.
How Single IRB Review Mandates Help Research Sponsors
The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Unique First-in-Human Phase I IRB Considerations you Might not Know About
An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.
eReg Benefits for Clinical Research: Use Cases for all Types of Sites
Using an eRegulatory system can benefit any site, helping to increase productivity, improve compliance, and save money.
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.
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