Reporting Requirements
Beginner’s Guide to Minimal Risk Research
How can researchers know when research is minimal risk? Learn an overview and the regulatory flexibilities that might be eligible.
Do You Have Appropriate Oversight? Understanding the Role of DSMBs
Take a look at the role and function of independent DMCs from charter creation through interim data analysis to prepare your next trial.
Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Learn how to ensure compliance with FDA 21 CFR 312.32, and explore Advarra solutions that support efficient and compliant safety reporting.
Site-Driven Metrics: Operational Data To Improve Research
Most metrics are geared toward sponsors and CROs, find out how this ultimately impacts site research operations
Thorny Issues in Medical Device Research
Learrn how to navigate thorny issues in medical device research, including which regulatory requirements apply to different types of device studies.
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.
Social Media for Research Recruitment: Ethical and Practical Aspects
Luke Gelinas, IRB Chairperson at Advarra, addresses ethical and practical issues involved with social media recruitment.
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.
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.
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.
Q&A Part II: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
Part 2 of Q&A from the Clinical Trial Feasibility: Ensuring Success for Clinical Sites webinar outlining why it is important for sites to approach research operations as a business.
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