ICH-GCP Guidelines and Research Conducted in the US
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?
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)
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
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
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
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
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
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
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
In medical device research, the determination of “significant risk” or “nonsignificant risk” can sometimes be confusing, especially for those new...
