CRO
VERO Biotech Gains FDA Approval for Complex Drug and Device Combination
Learn more about how VERO Biotech leveraged Advarra Consulting to successfully navigate the pathway to FDA approval
Research Equity and Enrolling Non-English Speakers
This blog explains how including participants with limited English proficiency (LEP) can help improve research access and diversity.
Adapting, Adopting, and Succeeding in a Decentralized Landscape
Join a discussion on the exponential evolution of clinical trials, uncover trends observed across the industry, and hear how leading research organizations have adapted to a decentralized landscape.
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