Research Compliance
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.
How to Be Research Ready: Today and Beyond
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.
World’s Largest CRO Leverages Partnership With Integrated Central IBC to Initiate Sites in COVID-19 Vaccine Research at Warp Speed
Advarra’s IRB and IBC reviews and Gene Therapy Ready site network helped reduce study startup timelines and delivered trial results to the sponsor quicker than expected.
What Is an Institutional Biosafety Committee?
An institutional biosafety committee (IBC) ensures research is conducted safely and in compliance with the NIH guidelines. Watch our video to learn the role of an IBC.
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.
What is Coverage Analysis in Clinical Research?
This infographic outlines the importance of coverage analysis, consequences to non-compliance, and solutions to avoid non-compliance.
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.
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
Q&A from our 4/21 webinar outlining what to expect in an FDA inspection and how to have a more positive experience.
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
Meridian Builds Robust Gene Therapy Research Program
Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines.
Realizing the Benefit of Mobile Technology in Your Clinical Trial
The use of mobile technology has been trending since smart phones hit the mainstream over 10 years ago. But the life science industry is still in the early stages of figuring out how to use mobile devices to deliver value to clinical trial patients and sponsors.
FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
A Food and Drug Administration (FDA) inspection of a clinical investigator can occur at any time. The FDA conducts inspections of clinical investigators to verify clinical trial data submitted to FDA; to ensure that the rights, safety, and welfare of human subjects enrolled in FDA-regulated clinical trials are protected; and to assess regulatory compliance.
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