Institutions
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.
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.
Diving into Single IRB Implementation
In this episode, we get an inside look at how institutions implement sIRB requirements and how to overcome potential challenges.
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
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.
Is Your Site Ready for an FDA Inspection?
Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.
Beginner’s Guide to Medicare Coverage Analysis
Medicare coverage analysis evaluates how clinical research protocol items and services are billed per federal agency guidelines.
Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
Developing and Implementing a Successful eConsent Process
As the industry continues to shift from brick-and-mortar trials to more convenient hybrid formats, eConsent proves to be useful.
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