CRO
Understanding International Data Transfer’s Impact
Read our blog to understand some of the data privacy implications facing international clinical research.
FDA Communications Through the Drug Development Lifecycle
Understand how to effectively communicate and build a relationship with the FDA throughout the drug development lifecycle.
ReadyQMS Info Sheet
Advarra ReadyQMS, a quality management system for biopharmaceutical companies, reduces risk and ensures regulatory compliance.
Data Integrity – It’s All About the Data!
This blog dives into data integrity in clinical research, including how to obtain and maintain data throughout its lifecycle.
6 Tips for Creating Effective Clinical Trial Training
This blog offers practical tips for effective site training to ensure your global clinical trials are compliant and efficient.
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.
FWAs Part 2: Managing a Federalwide Assurance and IRB Registration
Join Advarra’s regulatory experts in another discussion of institutional and IRB responsibilities and dig deeper into the FWA topic.
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.
Ethical Issues in the Design and Review of Decentralized Research
This white paper aims to provide a framework to understand ethical issues and steps to take in deploying a decentralized trial
Beginner’s Guide to Independent Asset Reviews
Learn more about independent asset reviews and how they can enhance research operations.
James Riddle and Barbara Schneider Delve into the Different Players Involved in Reviewing Clinical Research
In this podcast episode, we discuss the different clinical research oversight committees and functions to ensure the safety of participants.
Why it is Critical to Have and Enforce a Data Strategy?
Understand a data strategy's role in clinical research and how enforcing one will benefit your studies.