CLINICAL TRIALS IN RUSSIA BUSINESS CONTINUITY PULSE APRIL 1, 2022
Dear Customer Colleagues,
As Syneos Health has communicated in previous Business Continuity Pulse Updates, our focus continues to be on the care of our employees and their families, safety for clinical trial participants and sites, humanitarian efforts and support for our customers.
We are proactively monitoring the evolving crisis 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, as well as sanctions, in an effort to maintain operations where feasible.
STATUS OF CLINICAL STUDIES IN RUSSIA
Syneos Health continues to closely monitor the situation in Russia with a focus on the evolving economic sanctions and supply chain disruptions. As these challenges persist, we continue to assess the impact using a risk-based approach to help formulate and adapt our recommendations regarding clinical studies in Russia. This communication contains important updated information about the evolving sanctions situation, and its impact on our prior recommendations to wind down clinical studies in Russia.
On 24 mars 2022, the US issued an updated General License that allows Syneos Health to make payments to most sites for ongoing clinical trials that were in effect as of 23 mars 2022. As a multinational company, Syneos Health may still be bound by other sanctions regimes. Syneos Health is working with our Sponsors and their sites, investigators and vendors to identify any that use other banks subject to non-US sanctions and determine if they can make alternate banking arrangements.
We want to be clear that Syneos Health is not recommending halting ongoing studies in Russia, at this time.
Though payment to current sites in Russia may now be permissible under US sanctions due to the updated General License, we will continue to assess the logistical challenges that are persisting in Russia, such as the ability to import and distribute investigational product. As a result of the current operating environment in Russia, we still have patient recruitment on hold and have stopped initiating new clinical trial activities in Russia. On a case-by-case basis, however, Syneos Health is willing to carefully review Sponsor and project team requests to resume recruiting clinical trial participants at current sites for life threatening or severe conditions.
Syneos Health will continue to take a risk-based approach on making individualized recommendations to clients based on the circumstances of each study. We want to strongly emphasize that everything we recommend is always with the best interest of patients, research sites and customers in mind.
ACRO UPDATE
In our 4 mars 2022, Business Continuity Update, we shared information about the meeting held between the Association of Clinical Research Organizations (ACRO), Syneos Health and other ACRO members. As we reported in that update, all ACRO members are experiencing similar challenges in conducting clinical trials in Ukraine and Russia. The ACRO members are overwhelmingly aligned in our shared response to focus on the health and safety of employees and research study participants, as well as strategies for business continuity.
Following the 3 mars 2022, ACRO meeting, members compiled a list of questions and recommendations for the monitoring of ongoing trials, data management, documentation, logistics and continuity. The questions were shared with the U.S. Food & Drug Administration (FDA), the European Medicines Agency, the Ukrainian Ministry of Health and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ACRO members are hopeful the agencies will find this information useful as they formulate a response to the crisis in Ukraine.
We continue working with the regulatory bodies in collaboration with ACRO to provide industry guidance and will provide regular updates to our customers.
BUSINESS CONTINUITY PLANNING CADENCE
We are regularly updating our Ukraine Resource Center. Please visit our Resource Center to learn more.
Thank you for your partnership during these times of crisis.
