IRB
Budgeting for Single IRB Review
A practical discussion of budgeting considerations for sIRB review, including strategies for policies around external IRB reliance.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Insights into the site selection process and the information sites provide as part of site feasibility questionnaire completion.
Grant Application Checklist
Designed to be a starting point for grant conversations at your organization, this identifies elements to include in applications and budgets.
CBD Research: A Dive into the Regulations of Cannabis Research
With cannabis usage becoming more popular, there’s an uptick in research surrounding its therapeutic effects.
Beyond Pharmaceuticals: Research Involving Cosmetics, Conventional Foods, and Dietary Supplements
Explore regulatory frameworks applicable to research involving cosmetics, conventional foods, and dietary supplements.
Short Form Consents and the Unexpected Non-English Speaking Participant
What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
Top Barriers to Participation in Clinical Trials
Understanding the factors that influence the decision to participate in a study helps research professionals diagnose enrollment problems.
Return of Research Results to Study Participants
Research into participant experiences has consistently shown their desire to learn the results of research to which they’ve contributed.
IRB Review of Decentralized Trial Technology
Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.
Patient Recruitment and Enrollment in Clinical Trials
Learn more about patient recruitment and enrollment: how they find out about clinical trials and the reasons they participate.