Research Operations
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.
Strategies for End-user Adoption
Learn about potential solutions to help you create new adoption strategies, materials, and build training to optimize end-user acceptance.
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
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.
Understanding how to Build and Leverage a DSMB Statistical Plan
Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.
What is a Quality IRB Review?
Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.
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