IRB
Advarra IRB Chairperson Featured in PRIM&R Blog About Patient Centered Outcome Research
Advarra IRB Chairperson Luke Gelinas was recently featured in the PRIM&R blog post Recommendations for Oversight of Patient-Centered Outcomes Research
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete.
ICH-GCP Guidelines and Research Conducted in the US
Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.
Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!
Judith Carrithers and discuss a checklist of action items to consider and complete prior to the revised Common Rule compliance date.
Oversight Challenges with Patient Centered Outcomes Research
In this webinar, Luke Gelinas, PhD, IRB Chair at Advarra, lays out some of the oversight challenges raised by PCOR.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.
IRB Services for Institutional Sites
Advarra serves as your external support and compliance partner for everything from single investigational sites to multisite research consortia and therapeutic networks.
The EU General Data Protection Regulation: Implications for Research
Leslie Thornton and Nick Wallace provide an introduction to the GDPR and its potential application to the US-based research community.
The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)
Please note that this material is provided for informational purposes only and not for the purpose of providing legal advice.
Integration Update: Recent Milestones Completed
The Advarra team has worked to fully integrate our processes and policies to provide clients with unified capabilities and support for IRB, IBC and global research quality and compliance consulting services.
Expanded Access and Right to Try: The Impact of Recent Legislative Changes
This webinar provides an overview of the current state of the FDA’s Expanded Access Program and state and federal “Right to Try” legislative efforts.
Navigating the Expanding Regulations of ClinicalTrials.gov Registration and Results Reporting
Anthony Keyes reviews the federal regulations regarding registration and results reporting of clinical trials.
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