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.


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...


Schulman IRB and Chesapeake IRB Merger and Integration: What You Need to Know

November 30, 2017

On November 7, 2017, we announced that Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra....


Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know

October 31, 2017

On October 1, 2017, NIH’s policy for certificates of confidentiality (CoCs) changed so that CoCs are now automatically issued for...


“Significant Risk” and “Nonsignificant Risk” Determinations for Medical Devices

October 31, 2017

In medical device research, the determination of “significant risk” or “nonsignificant risk” can sometimes be confusing, especially for those new...