FDA Inspection Readiness: After the Inspection
In the final part of the three-part FDA inspection readiness series, we will go into detail about what to expect
Consulting
FDA Inspection Readiness: During an Inspection
In our previous blog, FDA Inspection Readiness: Preparing for an Inspection we reviewed how to prepare for a Food and
GCP Assessment During COVID – “Did Your Clinical Trials Remain GCP Compliant During COVID-19?”
We are now almost a year into the COVID-19 pandemic, and you may be asking whether your clinical trials remained
Informed Consent: When, Why, and How It’s Obtained
Informed consent isn’t just a formality—it’s an evolving process that safeguards participant autonomy and enhances study integrity from start to finish.
Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
In a recent webinar, James Riddle, Shannon Roznoski, and Stuart Cotter of Advarra presented Regulatory Fine Points: Exploring 21 CFR Part
Expanding Our Global Consulting Expertise to Solve Mission-Critical Issues
Elevating our consulting capabilities to accelerate clinical research and bring therapies to market sooner. YourEncore, a leading provider of drug
Top 10 Educational Resources of 2020
It’s safe to say 2020 has been more unpredictable than anyone could imagine. Through these unprecedented times, we have worked to provide the
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures
Q&A – Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
In our latest webinar, a panel of experts from research organizations, Community Health Centers (CHCs) and healthcare tech discussed racial
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
As part of FDA’s response to combat COVID-19, FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The
By the Numbers: Our Response to COVID-19
We are honored to support a resilient research community during the COVID-19 pandemic. See the data points in our infographic to find out how Advarra helps keep research moving forward.
Beginner’s Guide to Investigator-Initiated Trials
While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials