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The Power Of Patient Advocacy In Drug Development
This blog outlines the origins and rise of patient advocacy groups, discussing the milestones in the FDA's acceptance of these groups.
Q&A from Remote Monitoring: Study Compliance In A Changing World
In a recent webinar, Advarra experts provided insights and information in Remote Monitoring: Study Compliance in a Changing World
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an Investigational New Drug (IND) application for the first time? Consider three common CMC pitfalls that may impact submission.
The State of Clinical Trial Activation at Sites
While the study activation process is necessary for all sites to conduct, efficiently coordinating all necessary aspects can be challenging.
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
Summary of James Riddle's Presentation at SQA, which outlines considerations for sponsors when ensuring 21 CFR Part 11 compliance at sites.
Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
Read how an eRegulatory system can increase productivity, improve compliance, and ensure a return on your technology investment.
BBK Worldwide Features Advarra Executive Michele Russell-Einhorn in Diversity and Inclusion Video
This video discusses methods IRBs can implement to increase diversity and inclusion among trial participants.
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
Engaging with an expert research compliance partner throughout the clinical development process allows researchers to focus on what matters
3 Strategies to Successfully Engage Participants in Your Trial
A positive participant experience underpins the success of any clinical trial. Leverage these key strategies to ensure success.
Q&A Part II with Dr. Wendy Tate, Author of Insights Accrual Prediction Algorithm
This March, Insights Accrual Prediction platform was released to pilot customers. The second issue of our Q&A series continues our conversation with Dr. Wendy Tate, the author behind the machine learning tool’s algorithm, to hear her experience bringing this innovative tool to the research community and get her perspective on what comes next.
Q&A Part I with Dr. Wendy Tate, Author of Insights Accrual Prediction Algorithm
This March, Insights Accrual Prediction platform was released to pilot customers. We sat down with Dr. Wendy Tate, the author behind the machine learning tool’s algorithm, to learn what inspired her to tackle this industry hurdle and hear her experience bringing this innovative tool to the research community.
Understanding the Complexity and Uniqueness of Phase I Trials
There are many distinctions that set Phase I trials apart from the rest. For sites aiming for a successful Phase I trial, working with an organization that understands the nuances is key.
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