Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
The past year has been one of the most challenging ever for those working in healthcare and clinical research. The
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Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of Clinical Investigators: Understanding the Process
Q&A Part II with Dr. Wendy Tate, Author of Insights Accrual Prediction Algorithm
This week, Advarra launched a pilot of the Insights Accrual Prediction platform to customers, powered by Wendy’s initial model and
Q&A Part I with Dr. Wendy Tate, Author of Insights Accrual Prediction Algorithm
In every aspect of her research career, Dr. Wendy Tate, Director of Research Operations at Advarra, has been committed to
Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs
Centralizing subject binders and SOPs in an eRegulatory system streamlines remote monitoring, ensuring secure access, compliance, and future-ready workflows.
Understanding the Complexity and Uniqueness of Phase I Trials
In clinical research, working with organizations that understand the ins and outs of the phase of your trial is key
mRNA and Its Role in Clinical Research
In the race to address the COVID-19 pandemic, researchers have worked tirelessly the past year to produce a vaccine. Operation
Does Warp Speed Vaccine Development and Testing Compromise Safety?
A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while traveling at warp speed or
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
Standardization and the Importance of Medical Coding Dictionaries in Clinical Trials
The data gathered in a clinical trial is often collected by many different people, including investigators and coordinators, and interpreted
The Many Faces of “Coercion” and “Undue Influence”
The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar