Navigating the FDA Emergency Use Filing Process
In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one
Consulting
Developing an Emergency Preparedness Plan for your HRPP
The COVID-19 pandemic highlighted the importance of robust emergency preparedness for HRPPs, ensuring research continuity and participant protection during crises.
For FDA Inspection Readiness, Accountability is Key
Dawn Wydner, former Food and Drug Administration (FDA) Consumer Safety Officer, LCDR, and current Managing Expert for Advarra’s Quality Center
Top 10 Educational Resources of 2021
The year 2021 brought many advancements in the clinical research industry. We’ve pushed for more diversity and inclusion in clinical
Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the first in the webinar series – FDA Updates: BIMO
The Key to Increasing Diversity in Decentralized Trials
Historically, decentralized clinical trials (DCTs) were heralded as the future of patient-centered research. But how can your organization “walk the
How Advarra Helps Institutions
Transcript Institutions, universities, academic medical centers, hospitals, and healthcare systems all play a critical role in clinical research. In the
Future of Work in Clinical Research
When SARS-CoV-2 (the virus causing the disease COVID-19) broke out in 2020, the clinical research community needed to pivot quickly
Reflections from Cell and Gene Meeting on the Mesa 2021
I recently had the privilege of both presenting at and attending the 2021 Alliance for Regenerative Medicine (ARM) Annual Cell
Implementing a Quality Management System
Many research and development (R&D) organizations across the industry have limited access to a quality department in the early stages of
Advarra Trend Report: The Future of Work in Clinical Research
Advarra conducted The Future of the Clinical Research Workforce survey in Summer 2021. This report reflects the survey’s findings.
Beginner’s Guide to Connected Clinical Research Ecosystems
A well-managed, participant-centric clinical trial has many moving parts, and easy access to the right technologies, services, and community of