Institutions

While many US researchers are aware of the coming Common Rule changes, not everyone is sure whether they will need to comply with the revised regulations.

Given the growth in gene therapy research, sponsors, CROs and sites have become increasingly curious about the requirements to be able to conduct such studies.

The Advarra team is proud to announce that all major integration activities are now complete.

Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.

The Advarra team has worked to fully integrate our processes and policies to provide clients with unified capabilities and support for IRB, IBC and global research quality and compliance consulting services.

The following FAQ expands upon previous FAQs we’ve published and provides additional insight into the integration process.

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. Lauri Carlile, VP of Operations at Advarra, discusses the basics of ex-US research ethics review for US-based researchers.

New to clinical research? Learn the meaning of common industry acronyms and abbreviations including eCRF, IIT, PI, TMF, and more.

Since November 2017, the Advarra team (formerly Chesapeake IRB and Schulman IRB) has been working to integrate our process and policies. We are committed to being transparent throughout this integration, so we've assembled the following FAQ to keep you updated.

Learn the necessary steps to create an effective SOP for data collection in clinical trials when using an electronic data capture (EDC) system.

Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra. This FAQ addresses commonly asked questions about this merger.