Do I Need to Comply With the Revised Common Rule?

January 18, 2019

Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of...


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...


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...


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...


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....


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...


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...


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...


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...


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.