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

November 30th, 2017 by Julie Blasingim, Director of Change Management at Schulman IRB, and Lauri Carlile, Executive Director at Chesapeake IRB

On November 7, 2017, we announced that Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra. Our teams are excited to work with a like-minded organization and for the new opportunities this merger offers, and the overwhelmingly positive response we’ve received from the research community thus far reaffirms our confidence in the value of this venture.

We understand that questions and uncertainty often spring from big changes like the merger of two large, industry-leading organizations. As we proceed through the integration process, we are committed to providing proactive answers and support to our clients. We will be transparent and communicative so that you have the information you need to continue your work with as little interruption as possible.

To that end, we’ve assembled the following FAQ to address some of the most commonly asked questions about this merger. If you don’t see your question addressed here, please contact your Study Coordinator or Study Manager or email info@advarra.com.

Stay tuned for further integration information via email, blog, webinar and other communication formats.

Integration FAQs: The Basics

Q: What will happen to my existing studies?

A: Over the next few months, there will be no changes to currently active studies. They will remain with the IRB that originally reviewed the study, and any written IRB correspondence/documentation will be issued from the reviewing IRB. Your current study contacts and timelines will not be affected.

As Chesapeake IRB and Schulman IRB progress through the integration process, we will be harmonizing and optimizing our processes, technology platforms and standards of practice to ensure our combined clients are provided with and have access to the most efficient, customer-focused and highest quality service provider in the industry.

 

Q: Do I have to use a different submission form or system?

A: Please continue to use the current submission forms and processes for Chesapeake IRB and Schulman IRB. There will be no immediate changes to the Chesapeake IRB and Schulman IRB submission platforms and processes.

As Chesapeake IRB and Schulman IRB progress through the integration process, we anticipate migrating to a common electronic platform to better serve our clients. Changes will be communicated and coordinated with you in advance. Any training needs will be provided on a routine and ongoing basis.

 

Q: Will there be any changes to existing contracts?

A: All existing confidentiality agreements, MSAs and contracts remain valid, and the terms of these agreements will continue to be observed. As new agreement templates are developed for the combined organization, we will coordinate any changes with you directly.

 

Q: I have fee schedules for both Chesapeake IRB and Schulman IRB. Can I use either one?

A: Chesapeake IRB legacy fee schedules will apply to submissions through the Chesapeake IRB platform, and Schulman IRB legacy fee schedules will apply to submissions through the Schulman IRB platform. Your Business Development representative will be happy to assist with any rate card or invoicing questions.

 

Q: Will you maintain your AAHRPP accreditation?

A: Yes, there will be no changes to our AAHRPP accreditation statuses.

 

Q: Will we need to update our FDA 1572 or Federalwide Authorization (FWA)?

A: All FDA 1572s and FWAs listing Chesapeake IRB and Schulman IRB remain in effect. If any updates are required moving forward, we will provide proactive guidance on changes necessary to meet regulatory requirements. 

 

Q: Will my primary contact change?

A: Please continue to communicate with your existing primary contacts at Chesapeake IRB and Schulman IRB. We will proactively communicate and coordinate any changes in personnel assignments.

 

Q: Will the composition of your review boards change?

A: All of the existing review boards for Chesapeake IRB and Schulman IRB will remain in place.

As integration proceeds, Chesapeake IRB and Schulman IRB boards will have access to the expertise of each other’s board members, providing even greater resources and expertise for the review of your study.

 

Q: How long do you expect integration will take?

A: We anticipate the integration process will take several months and up to a year to complete. Any changes to policies and procedures that impact you will be communicated to you in advance.

 

Q: Will there be any delays to my submissions?

A: There will be no impact or delays to your study submissions. Current processes and review boards will remain in place. All of our integration planning and efforts are focused on making sure the work gets done with the same industry-leading quality and timeframe you have come to expect.