BUSINESS CONTINUITY PULSE: RUSSIA SANCTIONS AND EMA GUIDANCE APRIL 7, 2022
Dear Customer Colleagues,
As Syneos Health has communicated in previous Business Continuity Pulse Updates, our priorities remain care for our employees and their families, safety for clinical trial participants and sites, support for our customers and continued focus on humanitarian efforts.
We are proactively monitoring the evolving war in Ukraine and will continue an ongoing cadence of communications to keep you updated on the impact of the war on customer studies in Ukraine and Russia, including due to sanctions, and our approach to maintaining operations in the region where feasible.
We are happy to report that we have now made contact with all of our Ukraine-based employees who have evacuated to safer locations in Western Ukraine or outside the country. In addition, as part of our business continuity activities, we continue to closely monitor the broader impacts of the war on neighboring countries and Europe in general. The impacts could potentially include 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. At this time, we continue to be alert for any wide-spread impacts affecting our industry and will continue to closely monitor the overall healthcare environment and clinical trial capabilities of the region.
STATUS OF SANCTIONS IN RUSSIA
On March 24, 2022, the United States issued an updated General License that allows Syneos Health to make payments to most active sites in Russia for ongoing clinical trials in effect as of March 23, 2022. Though payment to most active sites in Russia is now permissible due to this change, Syneos Health, as a multinational company, may still be bound by other sanctions regimes. Our project teams have an understanding of these changes and their impact on customers; they continue to communicate regularly with Sponsors, sites and investigators, and provide guidance on a case-by-case basis.
Due to the ongoing war, Syneos Health continues to have patient recruitment on hold, and we have stopped initiating new clinical trial activities in Russia. We are working with impacted customers, recognizing there are circumstances that may justify exceptions to a recommendation, and understand every study, team and customer has unique circumstances, including particular disease area, patient response to therapy, logistical issues or site needs.
We want to strongly emphasize that everything we recommend is always with the best interest of patients, research sites and customers in mind. Thus, on a case-by-case basis, we are willing to carefully review Sponsor and project team requests to resume recruiting clinical trial participants at current sites for life-threatening or severe conditions.
EMA GUIDANCE ON CLINICAL TRIALS
On March 31, 2022, the European Medicines Agency (EMA) issued new guidance to Sponsors managing the impact of the war in Ukraine on clinical trials. The joint statement between the EMA and the Heads of National Competent Authorities throughout the EU/EEA recognizes the inevitable interruption and need for advice on how to deal with the impact of protocol deviations and other consequences of disruptions.
Both agencies have recommended that Sponsors follow the initial COVID-19 guidance provided in the documents below:
- Guidance on the management of clinical trials during the COVID-19 pandemic
- Points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials
Additional Ukraine specific advice related to circumstances linked to the war is in development by the Clinical Trials Coordination Group, including recommendations on the methodological aspects of data stemming from clinical trials impacted by war in Ukraine.
BUSINESS CONTINUITY PLANNING CADENCE
We are regularly updating our Ukraine Resource Center. Please visit the Resource Center to learn more.
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