Research Operations
Scale Your Training Program: 3 Successful Models
Finding the best training solutions begins with understanding your organization’s training needs.
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.
Beginner’s Guide to 21 CFR Part 11 Compliance
FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.
Regulatory, Clinical, and Quality Considerations for Device Research
Medical device manufacturers are facing increasingly complex pathways to successfully bring their innovative ideas to the market.
What Does an Endpoint Adjudication Committee (EAC) Do?
This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.
Oncology Innovations and Other Trending Topics from IRB Experts
Join colleagues from NCI-designated cancer centers to discuss the unique ways oncology has pioneered clinical trial advancements.
Budgeting for Single IRB Review
A practical discussion of budgeting considerations for sIRB review, including strategies for policies around external IRB reliance.
Regulatory and Ethical Considerations for eConsent in Research
If any part of your informed consent process involves an electronic component, you’re conducting eConsent.
An Evolving Regulatory Environment for Rare and Orphan Diseases
By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.
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.
Enhancing Research Conduct Using eConsent
The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.
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