Reporting Requirements
The Importance of Keeping DSMBs Independent
By ensuring the DSMB is truly independent from study conduct, sponsors make trial data more trustworthy and enhance public confidence.
US Medical Device Regulation 101
Speed the review process by understanding how medical devices are classified & what the IRB must review to approve device research.
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Find out how to address Phase I research challenges to enable efficient IRB review and timely study startup.
Understanding eSource, ePRO, and EDC
eSource, ePRO, and EDC are integral to efficient clinical research. This blog explores how they work together and their differences.
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.
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