BUSINESS CONTINUITY PULSE: ACRO/FDA UPDATES AND RUSSIA SANCTIONS APRIL 20, 2022

Dear Customer Colleagues,

Syneos Health continues to proactively monitor the impact of the war in Ukraine focused on caring for our employees and their families, safety for clinical trial participants and sites, and support for our customers and humanitarian efforts. As previously shared, we are heartened and relieved to report that we have made contact with all of our Ukraine-based employees who have evacuated to safer locations in Western Ukraine or outside the country. 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.

ACRO/FDA UPDATE

 

On avril 8, 2022, the Association of Clinical Research Organizations (ACRO) met with the U.S. Food and Drug Administration (FDA) to discuss challenges being observed across CROs working in Ukraine, and to seek the agency's advice on pressing trial components and concerns.

The discussion focused on the transfer of subjects from Ukraine to sites in other countries, the management and documentation of protocol deviations, the management of irretrievable data loss, statistical considerations and the potential impact on study endpoints, IP sourcing and management, as well as corporate social responsibility requirements.

The FDA recognizes many trial patients are moving to seek safety and may need to change trial sites. As a result, call participants discussed how best to enroll patients in new trial sites, as well as alternative procedures for monitoring and conducting trials during this time. The FDA is in close communications with the European Medicines Agency (EMA) who published new guidance last week (more details below).

We continue working with the regulatory bodies in collaboration with ACRO to provide industry guidance and will provide regular updates to our customers.

CTCG GUIDANCE ON CLINICAL TRIALS

In our avril 7, 2022, Business Continuity Pulse, we noted that the Clinical Trials Coordination Group (CTCG) was developing additional guidance related to the war in Ukraine. The CTCG has since issued guidance that is primarily focused on the transfer of clinical trial subjects from Ukraine to other EU/EEA sites. The full recommendations can be reviewed in the below document.

• CTCG recommendation to Sponsors on managing  the impact of the war in Ukraine on Clinical Trials

We continue to monitor for these updates and will share new guidance/advice from industry agencies and groups as applicable.

STATUS OF SANCTIONS IN RUSSIA

As previously communicated, on mars 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 mars 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, and they will 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 want to strongly emphasize that everything we recommend is always with the best interest of patients, research sites and customers in mind.

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.