Blog
Making the Most of Site Training: Lessons from the Pandemic
The investigator meeting and site initiation visit (SIV) are two critical milestones marking the beginning of a clinical trial for...
Ensure that your next remote site initiation visit is both productive and useful despite the virtual setting with these tips
The Power Of Patient Advocacy In Drug Development
Recently, we discussed the importance of connecting with advocacy groups in order to create more trial diversity. As a result...
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 Emily Eldh and Ben Shankle provided insights and information in Remote Monitoring: Study Compliance...
In a recent webinar, Advarra experts provided insights and information in Remote Monitoring: Study Compliance in a Changing World
Improving Study Activation Time for Gene Therapy Research
Gene therapies and genetically engineered vaccines are growing exponentially and will continue to become more popular. Per a report from...
With the growing popularity of gene therapy research and genetically engineered vaccines, sites need to understand study activation impacts
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug...
Submitting an IND application for the first time? Consider three common CMC pitfalls that may impact submission.
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
At Advarra, we strive to provide sponsors, contract research organizations (CROs), and sites with the knowledge they need to perform...
Summary of James Riddle's Presentation at SQA, which outlines considerations for sponsors when ensuring 21 CFR Part 11 compliance at sites.
How to Be Research Ready: Today and Beyond
A study opportunity is presented to your organization. How quickly and confidently could you take on the study? This is...
If presented with a new study, are you prepared to take it on? Efficient study activation can set the pace for a successful clinical trial.
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...
Read how an eRegulatory system can increase productivity, improve compliance, and ensure a return on your technology investment.
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 from our 4/21 webinar outlining what to expect in an FDA inspection and how to have a more positive experience.
Phase I Oncology Clinical Trials
In a recent blog, we described the complexity and uniqueness of Phase I clinical trials, outlining the fact that some...
This blog discusses what makes Phase I oncology trials complex and what IRBs need to know as they review a Phase I trial.
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...
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
Engaging participants and creating a positive experience throughout your clinical trial increases protocol compliance, participant retention, and future recruitment and...
A positive participant experience underpins the success of any clinical trial. Leverage these key strategies to ensure success.
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