FDA Proposes Revised IRB Regulations, Including Required sIRB for Multisite Trials
The FDA released two proposed rules intended to partially harmonize its current regulations with the Revised Common Rule.
Informed Consent Writing Tip Sheet
Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it.
How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
A Guide for Successful Cell and Gene Therapy Research
Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.
Your Guide to sIRB Mandates
This webinar offers insights to your pressing questions related to single IRBs and explores the key features of federal sIRB mandates.
Advarra Launches Dedicated Support Services for Research Grant Applicants
Services will help ensure researchers submit a complete budget application that avoids post-award financial shortfalls
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.
Secure Document Exchange Info Sheet
Secure Document Exchange offers a site-centric approach to managing and exchanging regulatory documents among sites, sponsors, and CROs.