Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
To maintain Part 11 compliance, research sites must validate electronic systems storing FDA-regulated records, safeguarding data integrity and accuracy.
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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
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts
3 Strategies to Successfully Engage Participants in Your Trial
Engaging participants and creating a positive experience throughout your clinical trial increases protocol compliance, participant retention, and referrals.
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
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
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