Blog

Informed Consent Changes in the Revised Common Rule

January 18, 2019

Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the...

Blog

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...

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...