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
Developing an Enterprise Roadmap to Post Authorization Safety Studies
Learn how an organization achieved organization-wide compliance and managed its post-authorization safety studies.
Expanding the Ecosystem to Better Serve You
Common Pitfalls in Preparing an IND Application
While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.
IRB Review of Decentralized Trial Technology
Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.
Common Elements of IRB Assessments
Like other IRBs, Advarra is subject to inspections from time to time. What standards are we measured against?
Why do Funding and Legal Structure Matter in Decentralized Clinical Trials?
Both sites and sponsors must consider how DCT funding and legal structures can impact sites and the study itself.
Q&A: Stepwise Implementation of a Clinical Quality Management System
Advarra expert Steffen Engel answers questions from the webinar, Stepwise Implementation of a Clinical Quality Management System.
Advarra Consulting Delivers Clinical Trial Management Oversight
Download this case study to learn how Advarra Consulting mitigated risks and enabled compliance for a medical device organization.
Complete Guide to FDA Inspection Readiness
Learn how to prepare for an upcoming FDA inspection, what to expect during the inspection, and steps to take following inspection close.
Research Billing Services Info Sheet
Advarra's research billing services can ensure proper research billing compliance, administration, and operations.
The Whole Product Approach
Learn how your organization can implement the Whole Product Approach and how Advarra uses this method to help research sites.