BUSINESS CONTINUITY PULSE: UPDATES REGARDING CLINCAL TRIALS IN UKRAINE & RUSSIA MAY 27, 2022
Dear Customer Colleagues,
As we’ve communicated previously, Syneos Health continues to proactively monitor the Ukraine war with a continued focus on caring for our employees and their families, the safety for clinical trial participants and sites, and support for our customers and humanitarian efforts.
Additionally, as part of business continuity, we continue to keep an eye on the broader impacts of the war on neighboring countries and Europe in general. These efforts include the potential impacts on shortages of healthcare professionals to support clinical trial activities, disruptions of active clinical trials, over-saturation of research sites and delays with starting new trials.
CLINICAL TRIALS IN UKRAINE
In western Ukraine, we are beginning to see some movement in onsite monitoring visits. While new site activations and new patient recruitment remains on hold as our default position, Syneos Health has enabled site activations and patient enrollment on a case-by-case basis. We continue to work in partnership with sites, Sponsors and regulators to deliver treatments where there is a severe unmet medical need.
Within Ukraine, and on a study-by-study basis, we are facilitating patient transfers to other neighboring countries, where feasible. Additionally, we have learned that vendors have resumed accepting kits, resupply orders and frozen sample deliveries to their central laboratories in some regions and testing of safety parameters locally is being considered depending on study requirements and sites’ capabilities.
Lastly, vendors and couriers have been able to resupply investigational medical product stock in western Ukraine, however, distribution to some regions remains impossible or significantly restricted.
CLINICAL TRIALS IN RUSSIA
In Russia, vendors are beginning to start operations in the country again as logistical constraints have improved. Notably, imports of investigational medical product into Russia are ongoing, and laboratory vendors are able to analyze samples from the country again as couriers are re-routing specimens via Turkey and the Middle East.
Despite these updates, and while some vendors have resumed operations, more and more companies are permanently discontinuing activities in Russia as a result of increased logistical challenges, including biopharmaceutical companies discontinuing clinical trials. Given the current circumstances, Syneos Health continues to work with sponsors to transition all newly planned clinical trials/sites to alternative locations outside Russia.
STATUS OF SANCTIONS IN RUSSIA
As previously communicated, on March 24, 2022, the United States issued an updated General License (GL 6A) that allows Syneos Health to make payments to most active sites in Russia for ongoing clinical trials in effect as of March 23, 2022. To be clear, this General License only applies to sites activated on or before March 23, 2022 and does not apply to new clinical trial activities after this date. Though payment to most active sites in Russia is now permissible due to this change, it has become increasingly challenging to conduct any efforts regarding new clinical trials in the country given the sanctions.
Notably, due to recently updated General License (GL 13A), US companies are authorized to pay taxes, fees, import duties, purchase or receive permits and licenses through 12:01 a.m. eastern daylight time on September 30, 2022. We are closely monitoring the status of the current authorization and expirations. Our project teams have an understanding of these changes and their impact on customers, and they will continue to communicate regularly with Sponsors, sites and investigators, and provide guidance on a case-by-case basis.
BUSINESS CONTINUITY PLANNING CADENCE
We are regularly updating our Ukraine Resource Center. Please visit the Resource Center to learn more.
Thank you for your partnership.