On April 20, 2020, Advarra announced its acquisition of IRB Company, Inc. (IRBco). The combined organization offers mutual customers expanded resources and efficiencies and continues Advarra’s dedication to developing altogether better capabilities that serve clients and protect research participants.
We’ve assembled this FAQ to address some of the most commonly asked questions about the IRBco acquisition. If you don’t see your question addressed here, please contact your Study Coordinator or email Business Development.
Q: Will my primary contact change?
Please continue to communicate with your existing primary contacts at IRBco. We will proactively communicate and coordinate any changes in personnel assignments.
Q: How long do you expect integration will take?
For IRBco customers, we anticipate a straightforward and swift integration to process transfer of oversight of open studies to Advarra. We will proactively communicate upcoming changes to our new clients as the integration progresses.
Q: What do I need to do now?
No action is necessary at this time. As we proceed with integration, any changes will be communicated and coordinated with you well in advance.
Q: We need to audit Advarra as a new vendor. How should we set this up?
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 IRBco 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.
Q: Do I need to update my ICF(s) from IRBco to Advarra?
Informed consent forms (ICFs) that are currently approved or are in the process of being approved through the IRBco AllianceNet portal will not be updated to reflect IRBco’s name change to Advarra. The IRB’s contact information in your currently approved ICF(s) is still applicable.
Advarra does not require clients to make this change, as we have the following process in place to alleviate any administrative burden to our clients:
Once your study has been migrated to the Advarra Center for IRB Intelligence (CIRBI) Platform, the ICF will be updated only when a protocol-level modification to a master ICF template is submitted. When this change occurs to the protocol-level ICF, that template and the associated approved site(s) ICF(s) will be updated to change the IRB’s name to Advarra. We will also update the footer to include Advarra’s versioning at this time.
This information will also be clearly outlined in the letter you will receive after your study has been migrated to the CIRBI Platform.
Q: Do I have to use a different submission form or system?
Please continue to use AllianceNet to submit materials for existing studies and sites overseen by IRBco. In the coming weeks, new study submissions for initial review will be transitioned to the Advarra CIRBI Platform. Clients may begin submitting new studies for initial review now via the Advarra CIRBI Platform.
Studies currently managed via AllianceNet will migrate to CIRBI in the coming weeks. Changes will be communicated and coordinated with you well in advance, and any training needs will be provided on a routine and ongoing basis.
Q: I've never used the Advarra CIRBI Platform. How do I get started?
Follow these steps to set up a new CIRBI account:
- Click here to register as a new CIRBI user.
- Complete the online registration form and click the “Register” button at the bottom right of the form.
- 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.
- 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.”
Q: What is the impact of the acquisition and name changes to 1572s?
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 IRBco’s IRB to Advarra. Clients should file the Note to File and no other assignment is required.
Q: Will there be any delays to my submissions?
There will be no impact or delays to your study submissions. Current processes and review boards will remain in place until further notices. 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.
Q: Will my studies migrate to a new IRB management platform?
Yes, your studies will migrate to the Advarra CIRBI Platform, Advarra’s cloud-based, fully integrated IRB management platform. All IRB submissions and activities are managed through CIRBI. Changes will be communicated and coordinated with you well in advance, and any training needs will be provided on a routine and ongoing basis.
Q: When are my studies migrating to the Advarra CIRBI Platform?
We anticipate completing migration at the end of June 2020.
Q: What is being migrated from AllianceNet to the Advarra CIRBI Platform?
Documents necessary for IRB operations and client needs will be migrated to CIRBI. Documents currently available in AllianceNet will remain accessible through the required data retention period, which is 3 years post-study closeout.
Q: What process will Advarra use to ensure my study information is properly migrated?
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 validated environment.
Q: Will I still be able to access information in AllianceNet?
Yes, clients will continue to have access to AllianceNet throughout the applicable study retention period. Clients will be able to access AllianceNet to retrieve/review previous study documentation as needed. Advarra will provide clients with advance notification and guidance regarding the eventual discontinuation of the legacy AllianceNet system.
Q: Is the acquisition complete?
Yes. Advarra’s acquisition of IRBco was completed on April 17, 2020. IRBco will continue to operate on its legacy IRB meeting schedule during integration. Advarra anticipates full integration of all operations, IT systems, IRB rosters, consulting engagements, and other service lines over the next several weeks.
Q: Will clients with Advarra contracts have a single point of payment for all invoices (both from Advarra and IRBco?)
All payments for invoices should be made to Advarra for existing IRBco invoices. We will work with customers to change their banking information from IRBco to Advarra.
Q: Are clients being updated to a new fee schedule?
Advarra will honor negotiated fee schedules for clients who have prices locked under contracts. Fee schedule requests should be sent to Business Development.
Q: Will there be changes to the method of payment for invoices distributed?
Effective upon acquisition, IRBco will no longer be issuing invoices under the IRBco name. Monthly invoicing for April will be issued under Advarra, and payment should be made to Advarra. Advarra accepts checks, wires, ACH, and credit card payments.
Q: I have an MSA with IRBco; what should I expect?
Advarra’s Contracts and Proposals Group (CPG) will be reaching out to assign current MSAs from IRBco 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.
Q: I have a reliance agreement or global institutional authorization agreement (IAA) with IRBco. What should I expect?
We anticipate IRBco’s IRB registration number with OHRP/FDA will be deactivated sometime in May. At that time, Advarra will release a 1572 Note to File regarding the transfer of studies from IRBco’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.
