Integration Update: Expanded FAQ for Advarra Merger Efforts

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The Advarra team (formerly Chesapeake IRB and Schulman IRB) continues to integrate our processes and policies, leveraging mutual strengths in technology, regulatory expertise and customer service to provide clients with high quality research reviews and unparalleled efficiencies.

The following FAQ expands upon previous FAQs we’ve published and provides additional insight into the integration process. We’ve also assembled a central list of all integration updates we’ve published so you can easily find any updates you might have missed.

We are committed to being transparent and communicative throughout this integration so that you have the information you need to continue your work with as little interruption as possible. If you don’t see your question addressed here, please contact your Study Coordinator or Study Manager, or email us.

Operational Impact FAQ

1. What is the methodology of the corporate integration?

The integration methodology, which has been successfully employed previously in 4 IRB and 1 IBC integrations, focuses on people, process and technology to ensure that the best practices of both organizations are captured and institutionalized.

By ensuring our people are actively involved in SOP harmonization activities and are well trained prior to and after the integration go-live date, we allow our teams to dedicate their efforts to maintaining the high level of quality and customer service that characterized both of our legacy organizations. We also provide robust training and personal support for our clients, which is augmented by dedicated Client Service Coordinators and Study Managers, to ensure a seamless client experience.

Our highly trained staff and managers review and update all SOPs to ensure we emerge with an enhanced set of policies that not only capture the best practices of both organizations but are also consistent with the needs of our clients.

Our proven technology is a key component in implementing our enhanced SOPs in a timely and consistent manner that enables us to quickly leverage best practices across our entire enterprise. Our cloud-based, 21 CFR Part 11 compliant IRB platform allows clients to easily view study documentation and interact with our staff to resolve any issues in a timely and collaborative manner.

2. How does Advarra plan to harmonize SOPs that the staff and IRB will follow?

Core SOPs and IRB policies are currently undergoing harmonization. Following an extensive and comprehensive gap analysis, current legacy Chesapeake SOPs are being used as the foundation to create harmonized and enhanced Advarra policies and procedures. By utilizing legacy Chesapeake SOPs as the foundation for Advarra’s SOPs, we are able to greatly expedite the integration process since they already capture procedures required for the use of the cloud-based CIRBI platform. Enhancement of the platform, which is the cloud-based system that Advarra will implement, is currently underway and is based on best practices from both legacy organizations.

3. When will the Advarra SOPs be finalized for the legacy Schulman/Chesapeake teams to work under?

Advarra SOPs will be finalized prior to the May 1, 2018, implementation date to allow adequate time for training Advarra staff and IRB members.

4. How will you ensure all staff are trained prior to May 1, 2018?

Advarra’s dedicated Quality Assurance Team will manage and track all staff and IRB member training. All Advarra SOPs will be finalized and all staff will be trained at least 2 weeks prior to implementation, scheduled for May 1, 2018.  

5. What will happen to legacy Schulman/Chesapeake SOPs?

All legacy SOPs will be retired and retained for reference.

6. For studies that were initiated under the legacy SOPs, will the new Advarra SOPs govern?

Yes, new Advarra SOPs will govern current active studies. However, there is little impact to client submission/reporting requirements since both legacy organizations are AAHRPP accredited and have similar policies and procedures governing client reporting requirements. Any changes impacting studies will be communicated prior to May 1, 2018.

7. How are internal operational processes being harmonized? What other processes are being harmonized?

Several internal working groups meet on a consistent basis to evaluate every policy, SOP, IRB reviewer form, submission SmartForm, etc. to harmonize all policies and procedures across the Advarra organization. The Institutional Official and Director of IRB Reviews (a position created specifically for this reason), along with other Advarra representatives, are meeting regularly to ensure consistency across all 10 IRB panels.

Other processes being harmonized include quality control, quality management, other IT platforms/systems and internal communication/escalation.

8. What is the impact of the merger and name changes to 1572s?

As indicated in our 1572 Note to File that was sent to our current client base, the 1572 will not require an update. In accordance with FDA guidance, there are only two situations when a 1572 must be updated:

1. When an investigator is participating in a new protocol that has been added to the IND
2. When a new investigator is added to the study

Since the 1572 is a sponsor form, the sponsor should ensure they have the appropriate contact information for the IRB; the contact information for Chesapeake or Schulman IRBs will not change. FDA is aware of the merger and has indicated that clients should email gcp.questions@fda.hhs.gov with any further questions or confirmation regarding 1572 updates.

If 1572s have not already been distributed to sites, we recommend the following:

Date	Submission Platform	Acceptable 1572 Entities
Prior to April 30th	Schulman eTools	“Schulman IRB” “Advarra”
Prior to April 30th	Chesapeake CIRBI	“Chesapeake IRB”
After April 30th	Advarra CIRBI Platform	“Advarra” If Schulman or Chesapeake, please reference the Note to File

9. Will Advarra use the existing CIRBI forms, or have the forms been updated to merge legacy Schulman and Chesapeake forms?

There will be one set of submission SmartForms for Advarra. The legacy Schulman and legacy Chesapeake forms have been merged into the new Advarra CIRBI SmartForms, which encompass the combination of information collected by both legacy Chesapeake and Schulman IRBs.

10. How will the merger impact an institution’s FWA? Do we need to reapply or update our FWA?

As with 1572s, an institution’s FWA will not require an update. Please reference the Contractual FAQ below and the 1572 Note to File for more information.

11. I had a dedicated Study Manager at Schulman and a dedicated Client Service Coordinator at Chesapeake. Who will be my primary Point of Contact at Advarra?

Advarra will work with each client to identify the best dedicated point of contact for their unique research portfolio going forward. We understand that while some clients may prefer a dedicated “service team,” others may prefer a primary point of contact that they currently work with at each legacy organization. We strive to provide the approach that works best for your organization. If you have questions or preferences, please contact Business Development to discuss.

12. I haven’t received any updates on the merger to date. How does Advarra ensure its customers are getting information about the merger?

Advarra is committed to communication and transparency regarding our merger and ongoing integration. We have distributed a number of merger-related email announcements and have also posted FAQ documents and other updates (such as the recent Note to File related to 1572s) on our legacy websites. These messages have also been shared via our social media accounts and through direct outreach by Advarra staff members.

If you are a current customer who has not received these email updates, we recommend you add news@advarra.com to your safe email sender list. If you are not a current customer and you wish to receive updates, you can sign up here or contact Business Development for further support.

You can access a complete list of all integration communications to date here.

IRB Structure FAQ

1. How will you ensure the processes between the IRBs are harmonized?

Advarra has a strong regulatory organizational structure in place to ensure streamlining, consistency and harmonization between all of our IRBs. These activities are overseen by the Chief Compliance Officer and the Executive IRB Chair, as well as the Director of Regulatory Affairs and the Director of IRB Reviews. In addition, all IRB reviews will be conducted under harmonized Advarra policies and procedures.

2. How were IRB members harmonized between the legacy IRBs, related to IRB member recruiting and qualification?

All legacy Schulman and legacy Chesapeake IRB members have appropriate expertise to serve as IRB members with Advarra and are appropriately qualified and trained to serve as IRB members. Going forward, the training of new Advarra IRB members will be standardized, combining the training materials used by both legacy organizations.

3. How many IRB meetings will be conducted per week?

Legacy Schulman held 5 regularly scheduled meetings a week; legacy Chesapeake also held 5 regularly scheduled meetings as well as 2 Canadian meetings a week. Going forward, Advarra will have 10 US and 2 Canadian IRB meetings per week. Some of these meetings will be comprised of specialized panels focused on device, Phase I, oncology and neurology research. With over 100 IRB members in the US and Canada, Advarra is able to accommodate rapid review timelines for all major therapeutic areas, research phases and other specialty areas.

5. Are IRB membership rosters available?

Updated IRB rosters will be available by April 27, 2018.

6. How will Advarra ensure transparency regarding which IRB reviews studies and where submissions are routed?

Advarra will be operating as a completely integrated company with 1 IRB in the US and 2 REBs in Canada. All reviews will be done by Advarra. All submissions will be made through a single platform, the Advarra Center for IRB Intelligence (CIRBI) Platform, and all communications and approvals will be through that same system. This fully integrated approach will provide a seamless, transparent experience to customers and help ensure consistent, quality reviews.

Technology FAQ

1. What is the methodology for merging legacy Schulman studies into CIRBI?

From 2015 through 2017, we developed a validated and flexible comprehensive import capability for the CIRBI platform to support 5 successful earlier integration projects. This capability has been fine-tuned and further improved with each successive data migration.

In preparation for migration to CIRBI, we have reviewed and imported the entire dataset housed in the legacy Schulman eTools system. All data in the CIRBI dataset is compared and reconciled with the data from the original database.

All data extracted from the legacy Schulman eTools system is staged in a validation environment using the same import tool. This allows us to validate the data and ensure that data integrity is maintained.

Because of the large volume of studies and studies to be migrated, we have identified weekly migration tasks, referred to as “sprints.” Each sprint is defined with a set of studies for a given client and associated sites for those studies. By defining the scope of the sprint, it allows us to work with groups of customers to establish a plan, discuss timelines and expectations and provide access and training to customers for CIRBI use.

2. How will sites get access to the CIRBI platform and what training will be provided?

Sites that are not currently registered in the CIRBI platform will be notified prior to Advarra registering each user on his/her behalf. Registration will occur as studies are being prepared for migration into the CIRBI platform. A large number of sites have been working with both organizations prior to the merger.

While the platform was designed to be very user-friendly, training will be provided to sites by request (both initially and ongoing) or through pre-scheduled webinars requested by sponsors/CROs. You will be notified if a webinar is scheduled by the sponsor/CRO on your behalf.

3. Will there be access to the legacy Schulman eTools for closed studies or items that are not migrating over?

All study documentation, either for closed studies that have not met the retention period or for documentation that will not be imported into the CIRBI platform, will be available to clients in eTools.

All historic documents for active or terminated studies that are currently available through eTools will remain in place through the document retention period (terminated date plus 3 years).

4. Is there a time that the legacy Schulman eTools will no longer be available, and if so, what is the plan for the documents stored there?

Documents stored in eTools will remain available until a given study is closed and the regulatory retention period has ended (terminated date plus 3 years).

5. How has the legacy Schulman staff been trained on CIRBI, and how has this been documented?

A significant number of IRB members and Advarra staff have already been trained and are working within the CIRBI platform, and the remaining IRB members and staff will receive training in April 2018. Training is documented in records maintained by our Quality Assurance Team.

Legal Structure FAQ

1. Is the merger complete?

Schulman and Chesapeake’s merger was completed November 7, 2017. Both companies are operating independently and conducting business under “d/b/a” status while operational integration and IRB harmonization efforts are underway. Advarra anticipates full integration of all operations, IT systems, IRB rosters and service lines by May 1, 2018.

2. What is Advarra’s legal structure?

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 6940 Columbia Gateway Drive, Suite 110, Columbia, MD, 21046.

3. What is the relationship between all of Advarra’s entities?

Schulman IRB changed its corporate name to Advarra, Inc. on December 12, 2017. The legal entity name change will extend to all Advarra, Inc. affiliates, including Chesapeake Research Review, LLC.

Both Schulman IRB and Chesapeake IRB will retain d/b/a status for an interim period and continue to operate under the parent company.

Advarra (legacy Schulman IRB), Chesapeake IRB, IRB Services and Advarra Consulting (legacy Falcon Consulting Group) are affiliate entities which share the common parent company of CS Intermediate Inc.

4. When will Chesapeake and Schulman be working as Advarra?

Schulman and Chesapeake’s merger was completed on November 7, 2017. Both companies are operating independently and conducting business under “d/b/a” status while operational integration and IRB harmonization are underway. Advarra anticipates full integration of all operations, IT, IRB, etc. by May 1, 2018.

5. What is the structure of the Advarra Corporate Leadership Team?

• Pat Donnelly, Chief Executive Officer
• Jeff Wendel, President and Chief Operating Officer
• Scott Uebele, Chief Financial Officer
• Randall Hein, President, Advarra Consulting
• Robann Cunningham, Senior Vice President, Business Development
• Michele Russell-Einhorn, Chief Compliance Officer and Institutional Officer
• Lauri Carlile, Vice President, Operations
• Nitin Uplekar, Chief Information Officer

For more information, please reference this news item.

Financial FAQ

1. Will Advarra need to update its registration in client vendor portals?

Advarra’s payment information is the same as legacy Schulman’s, and Chesapeake’s information remains unchanged. Vendors will simply need to update the vendor name. A W-9 is available to reflect the change in name. Requests for Advarra’s W-9 should be sent to the Accounting Team. Should we make a change in payment information for any entity, it will be communicated to all customers and vendors via written notifications that share the new payment information.

2. Is there a W-9 available for Advarra?

Yes, requests for Advarra’s W-9 should be sent to the Accounting Team.

3. Will clients with Advarra contracts have a single point of payment for all invoices (both from legacy Chesapeake and legacy Schulman?)

Currently, each entity has its own banking information. All remittance information is contained on each invoice. The long-standing banking information for each entity remains in place. We are in the process of harmonizing our treasury structure, and any related updates will be communicated to customers in connection with implementation.

4. Are clients being updated to a new fee schedule?

Advarra will honor negotiated fee schedules for clients who have legacy contracts with Schulman and Chesapeake. Advarra will also honor all fee schedules in place from 2017 that govern protocols submitted prior to January 1, 2018. All other clients have been updated to a new Advarra fee schedule, effective January 1, 2018. Fee schedule requests should be sent to Business Development.

5. Will there be changes to the method of payment for invoices distributed?

There are no changes at this time. Currently, each entity has its own banking information. All remittance information is contained on each invoice that is sent out. 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.

Contractual FAQ

1. I have an MSA with both Schulman and Chesapeake; what should I expect?

Advarra’s Contracts Team is actively engaging clients who have MSAs with both legacy Schulman and Chesapeake to consolidate under one Advarra MSA.

2. I have an MSA with Chesapeake; what should I expect?

Contracts with Chesapeake Research Review, LLC remain valid; however, Advarra’s Contracts Team will be issuing amendments to current MSAs to indicate the name change/assignment from Chesapeake IRB to Advarra, Inc. You will receive communication directly from Advarra’s Contracts Team. Questions regarding contract status should be sent to the Contracts Team.

3. I have an MSA with Schulman; what should I expect?

Contracts with Schulman Associates Institutional Review Board, Inc. remain valid; however, Advarra’s Contracts Team will be issuing amendments to current MSAs to indicate the name change/assignment from Schulman IRB to Advarra, Inc. You will receive communication directly from Advarra’s Contracts Team. Questions regarding contract status should be sent to the Contracts Team.

4. I have an MSA with IRB Services; what should I expect?

IRB Services will be updating its name to Advarra as well. Contracts with IRB Services remain valid; however, Advarra’s Contracts Team will be issuing amendments to current MSAs to indicate the name change/assignment from IRB Services to Advarra, Inc. You will receive communication directly from Advarra’s Contracts Team. Questions regarding contract status should be sent to the Contracts Team.

5. I have an MSA with Falcon; what should I expect?

Falcon Consulting Group, Inc. has changed its legal name to Advarra Consulting, Inc. This will not affect the validity of these contracts. The Advarra Contracts Team has provided our clients with a legal notice of name change. There is no action required by current clients. Questions regarding contract status should be sent to the Contracts Team.

6. I have an MSA with Provision; what should I expect?

Provision contracts will be assigned to Advarra Consulting Inc. The Advarra Contracts Team has notified Provision clients regarding the assignment of contracts. Questions regarding contract status should be sent to the Contracts Team.

7. I have a Reliance Agreement or Global IAA with Chesapeake; what should I expect?

Chesapeake’s IRB registration with OHRP/FDA will be transferred over to the Advarra (legacy Schulman) registration by May 1, 2018. Once effective, Advarra will contact clients with global agreements to amend their contracts to the Advarra IRB registration.

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.

8. I have a Reliance Agreement or Global IAA with Schulman; what should I expect?

Schulman’s IRB registration (IRB00000971) with OHRP/FDA and its FWA with OHRP have been renamed to Advarra (d/b/a Schulman IRB). Once effective, Advarra will release a Note to File to clients which they should store with their contracts. No other action will be necessary.

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 d/b/a for the entity to whom they were submitted.

9. My contract includes affiliate language. Who are Advarra’s affiliates?

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. (formerly known as Schulman Associates Institutional Review Board, Inc.)
• Chesapeake Research Review, Inc.
• 0988560 BC Ltd. (d/b/a IRB Services)
• Advarra Consulting Inc. (formerly known as Falcon Consulting Group Inc.)
• Provision Consulting

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