Stephanie Pyle, MFA, CIP

Regulatory Documentation Manager, Advarra

Latest Posts by Stephanie Pyle

Clinical research professionals talking and gesturing to a laptop

2026 DHHS Unified Agenda: Four Areas HRPP and IRB Leaders Should Watch

The U.S. Office of Information and Regulatory Affairs (OIRA), within the Office of Management and...

Read More...

2026 DHHS Unified Agenda: What Clinical Operations and Study Startup Teams Should Watch

Planned changes outlined in the U.S. federal government’s 2026 Regulatory Plan and the Unified Agenda...

Read More...

2026 DHHS Unified Agenda: What Clinical Research Leaders Need to Know

On July 3, 2026, the U.S. Office of Information and Regulatory Affairs (OIRA), within the...

Read More...

Impact of sIRB Mandates on Study Teams

As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while...

Read More...

SAE Reporting and the IRB: Adverse Events in Drug Studies

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as...

Read More...

4 Unique Challenges of Oncology Trials

Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address...

Read More...

Does Warp Speed Vaccine Development and Testing Compromise Safety?

A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while...

Read More...

Impact of COVID-19 Outbreak on Ongoing Research and Protocols Under Advarra IRB Review

Advarra has policies and processes in place to keep IRB operations functioning as normal during...

Read More...

IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider

In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus...

Read More...

NWABR Appoints Advarra Executive James Riddle to Board of Directors

The Northwest Association for Biomedical Research (NWABR) has appointed James Riddle, Advarra VP of Institutional...

Read More...

Revised Common Rule Single IRB Mandate Now Effective

Compliance with the single IRB mandate for cooperative research, as outlined in the revised Common...

Read More...

NIH Decision Tool Updated to Incorporate Revised Common Rule

NIH has updated its human subjects research decision tool to reflect changes brought about by...

Read More...
Login
Scroll to Top