Quorum/Kinetiq Acquisition & Integration:
What You Need to Know

A: We anticipate the integration process will take approximately 6 months. Any changes to policies and procedures that impact you will be communicated to you in advance.

A: There are no changes to the Advarra/Advarra Consulting, Inc. legal entities or standard operating procedures, so clients who have already qualified Advarra as a vendor should not need to re-qualify Advarra as a vendor. Any legacy Quorum/Kinetiq customers who have not yet worked with Advarra and wish to audit Advarra as a new vendor may request to schedule an audit by sending an audit request to Advarra’s Quality Assurance Team.

A: Over the next few weeks, 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 Quorum and Kinetiq continue 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.

A: Please continue to use OnQ to submit materials for existing studies and sites overseen by Quorum Review. Over the next few months, new study submissions for initial review will be transitioned to the Advarra Center for IRB Intelligence (CIRBI) Platform. Clients may begin submitting new studies for initial review now via the Advarra CIRBI Platform.

Studies currently managed via the OnQ platform will migrate to the Advarra CIRBI Platform in the coming months. Changes will be communicated and coordinated with you well in advance, and any training needs will be provided on a routine and ongoing basis.

A: Follow these steps to set up a new CIRBI account:

1. Click here to register as a new CIRBI user.
2. Complete the online registration form and click the “Register” button at the bottom right of the form.
3. Advarra will set up your account and send you an automated email with a temporary password. Use the information from that email to login to CIRBI.
4. To access brief how-to videos on using CIRBI, login to the platform, then click the “Reference Materials” tab located at the top left.
   • Click the hyperlink “Advarra IRB Reference Materials” in the short list of blue hyperlinks and orange folder icons.
   • Scroll down to the blue header labeled “CIRBI QuickNotes/Help” and click the hyperlink “CIRBI How-To Video – Account Set-Up.”

A: The 1572 will not require an update. This is a sponsor form. Clients should email gcp.questions@fda.hhs.gov with any further questions. Advarra will release a 1572 Note to File regarding the transfer of studies from Quorum’s IRB to Advarra. Clients should file the Note to File and no other assignment is required.

A: All of the existing review boards for Quorum Review currently remain in place.  As integration proceeds, Advarra and Quorum 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.

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.

A: We will be migrating studies in phases, or sprints; approximately 8 sprints are required to migrate all data from OnQ to CIRBI. Advarra will work with each client to determine the timeline and steps involved in the client-specific migration. Clients will be notified in advance of the migration.

A: Each sprint will take 1 week to complete. Clients will be notified when migration is complete.

A: Documents necessary for IRB operations and client needs will be migrated to CIRBI, including all current approved ICFs (excludes site-unique ICFs) and all current participant/recruitment materials at the study level. Documents currently available in the OnQ system will remain accessible through the required data retention period, which is 3 years post-study closeout.

A: The Advarra integration team has previously conducted similar migration projects. Using proven processes, the Advarra team will ensure the migration is done efficiently and securely. The process involves extensive validation to confirm data integrity, including data comparison using database scripts, comparison of import script logs with the input data, and executing import files in a validation environment.

A: Yes, clients will continue to have access to OnQ throughout the applicable study retention period. Clients will be able to access OnQ to retrieve/review previous study documentation as needed. Advarra will provide clients with advance notification and guidance regarding the eventual discontinuation of the legacy OnQ system.

A: If you do not have a CIRBI account, we will create one for you. Once your account is created, you will receive a system-generated email with a temporary password. If you already have a CIRBI account, you continue to use the same login credentials.

A: Advarra has a corporate policy for the Avoidance of Conflict of Interest. This policy outlines the separation of data and activities to assure appropriate separation and confidentiality between the activities of the IRB and Advarra Consulting.

A: CS Intermediate Inc. is the parent company to all of Advarra’s entities. The operating company Advarra Inc. is an Ohio corporation with headquarters located at 6100 Merriweather Drive, Suite 600 Columbia, MD 21044.

A: As a result of the acquisition, Quorum’s operations will be rolled into Advarra, and the combined company will operate as Advarra, Inc. Advarra, Inc. is comprised of the following affiliates and subsidiaries:

• Advarra Consulting, Inc. (wholly owned subsidiary)
• Chesapeake Research Review, LLC (affiliate)
• 0988560 BC Ltd. d/b/a Advarra (affiliate)
• Quorum Review Inc. (affiliate)

A: There are no legal entity changes to Advarra as a result of the acquisition. Advarra’s standard operating procedures (SOPs) remain unchanged, and the Advarra CIRBI Platform will continue to be utilized as part of our service offerings. Quorum/Kinetiq operations will integrate into Advarra’s operations and IT systems over the next few months, and all agreements will be moved to Advarra in a similar timeframe.

A: Currently the long-standing banking information for each entity remains in place. We are in the process of harmonizing our treasury structure, and all updates will be communicated to customers in connection with implementation.

A: Advarra will honor negotiated fee schedules for clients who have prices locked under task orders. For negotiated fee schedules under an MSA, Advarra’s Business Development Team will reach out to clients to determine the entity-level fee schedule that will apply to studies submitted to Advarra. Fee schedule requests should be sent to Business Development.

A: There are no changes at this time. Currently the long-standing banking information for each entity remains in place. We are in the process of harmonizing our treasury structure, and all updates will be communicated to customers in connection with implementation.

A: Advarra and Quorum are separate entities and maintain separate FEINs. Until banking information is harmonized, payments will be made to the entity noted on each invoice based on who the study is submitted to. W-9 documents for both Quorum and Advarra are available by contacting Advarra’s Accounting Team.

A: Contracts with Quorum will remain valid; however, Advarra’s Contracts and Proposals Group (CPG) will be reaching out to assign current MSAs from Quorum to Advarra and to indicate the name change/assignment and any necessary amendment. You will receive communication directly from Advarra’s CPG Team. Questions regarding contract status should be sent to CPG.

A: Contracts with Advarra, Inc. remain valid and will not require any amendment or assignment. Questions regarding contract status should be sent to Advarra’s Contracts and Proposals Group (CPG).

A: As part of the acquisition, Kinetiq services will be offered under Advarra Consulting, Inc. This will not affect the validity of these contracts; however, Advarra’s Contracts and Proposals Group (CPG) will be reaching out to assign current MSAs from Kinetiq to Advarra Consulting, Inc. and to indicate the name change/assignment and any necessary amendment. You will receive communication directly from Advarra’s contracts team. Questions regarding contract status should be sent to CPG.

A: We anticipate Quorum’s IRB registration number with OHRP/FDA will be deactivated sometime in Q2. At that time, Advarra will release a 1572 Note to File regarding the transfer of studies from Quorum’s IRB to Advarra. Clients should file the Note to File alongside their IAAs; no other assignment is required.

We recommend that clients with global reliance agreements or IAAs work with Advarra’s Institutions Team to enter into the global agreement under Advarra to ensure a smooth transition of services.

Once the IRB registration update is complete, clients will notice that approval documents and other templates will be under the Advarra name. Until that point, all documents will continue with the entity to whom they were submitted.

A: Advarra’s affiliate entities are all legal entities who share the common ownership structure of our parent company CS Intermediate, Inc. Those entities include Advarra, Inc., Quorum Review, Inc., Chesapeake Research Review LLC., 0988560 BC Ltd. (d/b/a Advarra), and Advarra Consulting, Inc.