Blog

Reporting to the IRB: Serious Adverse Events (SAEs) in Drug Studies

December 14, 2018

At Advarra, we often get questions about exactly what events should be reported to the IRB. We understand that “reportable...

Blog

Infection Control and Biosafety in Gene Therapy Research

October 29, 2018

Gene therapy research has moved from the realm of science fiction to mainstream clinical research. The maturation of this field...

Blog

Integration Update: Leading Compliance Adherence

October 15, 2018

The Advarra team is proud to announce that all major integration activities are now complete. SOPs have been harmonized; staff...

Blog

ICH-GCP Guidelines and Research Conducted in the US

August 29, 2018

When research is being conducted in multiple countries, determining which regulations apply to which country’s sites can sometimes be complicated....

Blog

What’s the Difference Between Right to Try and Expanded Access?

July 12, 2018

The right to try movement and recent passage of the federal right to try law have renewed public interest in...

Blog

The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)

May 24, 2018

The European Union’s General Data Protection Regulation (GDPR) goes into effect May 25, 2018, replacing the existing EU Data Protection...

Blog

Integration Update: Recent Milestones Completed

May 23, 2018

The Advarra team has worked to fully integrate our processes and policies to provide clients with unified capabilities and support...

Blog

Integration Update: Expanded FAQ for Advarra Merger Efforts

April 5, 2018

The Advarra team (formerly Chesapeake IRB and Schulman IRB) continues to integrate our processes and policies, leveraging mutual strengths in...

Blog

International Research and Research Ethics Review

March 8, 2018

Clinical research continues to grow throughout the world, with researchers looking outside the US for new and diverse subject populations to help develop and improve investigational therapies.

Blog

Integration Update: Revised FAQ for Advarra Merger Efforts

March 5, 2018

Since November 2017, the Advarra team (formerly Chesapeake IRB and Schulman IRB) has been working to integrate our processes and...