Blog
Beginner’s Guide to IRB Review of IVD Research
If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.
Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges
Discover how CTMS streamlines patient recruitment & management for successful clinical trials.
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.
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.
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.
NIH 2023 Data Management and Sharing Policy: What you Need to Know
Optimizing Your Data Management Plan: Best Practices for Biomedical Research under the NIH Data Sharing Policy
Honoring Clinical Trailblazers: 2023 Video Series
This series celebrates the groundbreaking achievements of four pioneers who defied the odds to change the course of clinical research forever
Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
Trial designs incorporating multiple endpoints to support efficacy are receiving increased focus from the FDA, including a recently published guidance.
What is a Quality IRB Review?
Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.