On November 9, Advarra announced its acquisition of IntegReview. The combined organization leverages strengths in supporting the research community with client service, regulatory expertise, and technology-enabled efficiencies to accelerate innovation, streamline research operations, support faster study startup, and advance clinical trials.
We will conduct business as usual, and clients will keep their current team for support, customer relationships, and implementation projects. IntegReview clients will continue to receive the high level of quality service that they have come to expect, while gaining access to the enhanced benefits the combined company will provide.
We understand that questions may arise as we bring our organizations together, so we’ve assembled this FAQ to address some of the most commonly asked questions about the IntegReview acquisition. If you don’t see your question addressed here, please contact your IntegReview Client Services team at email@example.com or your Advarra Business Development team at firstname.lastname@example.org.
Q: How will the acquisition impact our working relationship with IntegReview and Advarra?
A: The combined company will enjoy a greater depth of talent and experience than IntegReview and Advarra had separately. IntegReview and Advarra have assembled a dedicated team to work on integration efforts, so we can conduct business as usual and minimize any impacts to our clients. We are committed to transparency and effective and timely communications about any changes as we integrate, and as such we have put together a process and communication plan for managing updates to ensure you are informed in advance of any changes.
IntegReview and Advarra lead the industry in quality and service delivery. As always, we will maintain diligent adherence to the quality of our work, personalized client support, and turnaround times. Operational excellence and ease of use will remain at the forefront of our integration effort.
Q: Do you plan to offer more services?
A: We are tremendously excited about the strategic combination of IntegReview and Advarra that will allow us to further develop and accelerate innovation across IRB services, institutional biosafety committee (IBC) services, global research compliance consulting, and research technology solutions. We will also continue to look for opportunities to further expand our research compliance services for clients.
Q: How long do you expect integration will take?
A: We anticipate the integration process will take approximately six months. Any changes to policies and procedures that impact you will be proactively communicated.
Q: We need to audit Advarra as a new vendor. How should we set this up?
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 IntegReview 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: Will my primary contact change?
Please continue to communicate with your existing contacts at IntegReview and Advarra. We will proactively communicate and coordinate any changes in personnel assignments.
Q: Do I need to update my ICF(s) from IntegReview to Advarra?
A: Informed consent forms (ICFs) that are currently approved or are in the process of being approved through IntegReview’s IRBManager portal will not be updated automatically to reflect IntegReview’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: What will happen to my existing studies?
A: For now, IntegReview and Advarra will continue to follow their respective processes unchanged. As IntegReview and Advarra progress through the integration process, we will be migrating IntegReview processes, technology platforms, and standards of practice to Advarra’s. Throughout this process, our goal is to ensure our combined clients are provided with and have access to the most efficient, customer-focused, and highest quality services in the industry. We will proactively communicate any changes.
Q: Do I have to use a different submission form or system?
A: Please continue to use the current submission forms and process for IntegReview and Advarra. There will be no immediate changes to the IntegReview submission platforms and processes, but IntegReview studies will eventually be migrated to the Advarra Center for IRB Intelligence (CIRBI) Platform. These changes will be communicated and coordinated with you in advance. Any training needs will be provided on a routine and ongoing basis.
Note: There are a handful of accounts where Advarra and IntegReview have significant overlap. For these accounts, we recommend that they begin submitting all new studies via the Advarra CIRBI Platform as soon as possible to avoid future data migration.
Q: I’ve never used the Advarra CIRBI Platform. How do I get started?
A: 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: Will we need to update our FDA 1572 or Federal-wide Authorization (FWA)?
A: All FDA 1572s and FWAs listing IntegReview and Advarra remain in effect. The 1572 will not require an update. This is a sponsor form. Clients should email email@example.com with any further questions.
Q: Will you maintain your AAHRPP accreditation?
A: Yes. There will be no changes to our AAHRPP accreditation statuses. We plan to incorporate IntegReview into Advarra’s AAHRPP accreditation.
Q: Will the composition of your review boards change?
A: For now, all existing review boards for IntegReview and Advarra will remain in place, and the IRBs will continue to meet according to their current schedules. As integration proceeds, we will merge IRB membership into a single Advarra IRB, providing even greater resources, flexibility, and expertise for the review of your study.
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 for now. Our integration planning and efforts are focused on ensuring the work is completed with the same industry-leading quality and timeframe you have come to expect.
CIRBI Migration FAQs
Q: Why are my studies migrating from the IntegReview IRBManager Portal to the Advarra Center for IRB Intelligence (CIRBI) Platform?
A: The Advarra CIRBI Platform is Advarra’s cloud-based, fully integrated IRB management platform. All IRB submissions and activities are managed through CIRBI, including studies previously overseen by Advarra’s legacy organizations.
Q: When are my studies migrating to the Advarra CIRBI Platform?
A: There will be no immediate changes to the IntegReview submission platforms and processes. IntegReview studies will eventually be migrated to the Advarra Center for IRB Intelligence (CIRBI) Platform. We believe the Advarra CIRBI Platform offers clients the most transparent and comprehensive submission and status tracking capabilities. We are committed to incorporating client feedback as we continue to make upgrades.
As we move forward in the integration process, we will coordinate any changes with you in advance and are always available to provide you with any training and support you require.
Q: What is being migrated from IRBManager to the Advarra CIRBI Platform?
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 IRBManager 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?
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.
Q: Will I still be able to access information in IRBManager?
A: Yes, clients will continue to have access to IRBManager throughout the applicable study retention period. Clients will be able to access IRBManager to retrieve/review previous study documentation as needed. Advarra will provide clients with advance notification and guidance regarding the eventual discontinuation of the legacy IntegReview IRBManager system.
Q: I’ve never used Advarra’s CIRBI Platform. How do I get started?
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.
Q: Is the acquisition complete?
A: Yes. Advarra’s acquisition of IntegReview was completed on November 2, 2020. Both companies will continue to operate in accordance with the legacy policies and legacy IRB meeting schedules during integration. Advarra anticipates full integration of all operations, IT systems, IRB rosters, consulting engagements, and other service lines within 6 months.
Q: What is Advarra’s legal structure?
A: The operating company Advarra Inc. is the owner of IntegReview, which is a wholly owned subsidiary.
Q: What changes have been made to Advarra as a result of the acquisition?
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 a part of our service offerings. IntegReview’s 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.
Q: Will Advarra need to update its registration in client vendor portals?
A: Advarra’s payment information will remain unchanged. As study submissions and consulting projects are transferred from IntegReview to Advarra, clients will receive invoices on Advarra letterhead, and we will communicate the Advarra remittance information to those customers along with their invoices. Should we make a change in payment information for any entity, it will be communicated to all customers and vendors via letters that share the new payment information.
Q: Will clients with Advarra contracts have a single point of payment for all invoices (both from Advarra and IntegReview?)
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.
Q: Are clients being updated to a new fee schedule?
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 firstname.lastname@example.org.
Q: Will there be changes to the method of payment for invoices distributed?
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.
Q: I was working with IntegReview. Do I need a new W-9 for Advarra?
A: Advarra and IntegReview 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 IntegReview and Advarra are available by contacting email@example.com.
Q: I have an MSA with both Advarra and IntegReview. What should I expect?
A: Advarra’s contracts team is actively engaging clients who have MSAs with both IntegReview and Advarra to consolidate under one Advarra MSA.
Q: I have an MSA with IntegReview; what should I expect?
A: Contracts with IntegReview will remain valid; however, Advarra’s Contracts and Proposals Group (CPG) will be reaching out to assign current MSAs from IntegReview 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@advarra.com.
Q: I have an MSA with Advarra; what should I expect?
A: Contracts with Advarra, Inc. remain valid and will not require any amendment or assignment. Questions regarding contract status should be sent to CPG@advarra.com.
Q: I have a reliance agreement or global institutional authorization agreement (IAA) with IntegReview. What should I expect?
A: IntegReview’s IRB registration number with OHRP/FDA remains active.
Q: My contract includes affiliate language. Who are Advarra’s affiliates?
A: Advarra’s affiliate entities are all legal entities who share the common ownership structure of our parent company Advarra, Inc. Those entities include Advarra, Inc., Quorum Review, Inc., 0988560 BC Ltd. (d/b/a Advarra), Forte Technologies, Inc., and Advarra Consulting, Inc.