Syneos Health is continuing to closely monitor the ongoing war in Ukraine. Throughout the crisis, we’ve consistently focused our Business Continuity Team support efforts on the safety and wellbeing of our colleagues, clinical trial patients, investigators and customers. We’ve kept customers informed of our latest efforts through regular and ongoing communications.
ENSURING SAFETY FOR PATIENTS AND SITES
With the Ukraine crisis continuing to evolve, patients and sites remain a high priority. Syneos Health continues to work with customers to evaluate and mitigate risks with patient safety and continuity top of mind. We are also working, as feasible, to ensure availability of investigational product (IP) and lab kits, transitioning from central labs to local labs and tracking patient status and safety.
We continue to adapt our strategic approach as the crisis escalates and are expanding risk assessments to neighboring countries to be proactive about potential future challenges.
Banking and economic sanctions imposed on Russia continue to present challenges to clinical trials. Our team is monitoring these sanctions to ensure compliance, and we are adapting our operations (where possible) to reflect the increasing logistical challenges.
DISCUSSIONS BETWEEN ACRO AND U.S. FDA
Syneos Health recently met with members of the Association of Clinical Research Organizations (ACRO) and the U.S. Food & Drug Administration (FDA) to discuss the impacts of war on clinical trials in the region. The primary focus of these meetings was patient and staff protections and data integrity. Syneos Health learned during these discussions that the industry is now largely aligned and taking a risk-based approach in conducting clinical trials, as companies are all experiencing similar issues in the region.
The FDA indicated that the Agency is aligned with ACRO member organizations with its top priority being patient safety and a continued focus on study continuity, where possible. The FDA also continues to monitor the situation and advised that companies “for now” lean on the principles put in place to respond to COVID-19, including remote monitoring, missing data and safety guidance, while acknowledging the significant differences between COVID-19 and war.
The FDA is asking for regular updates from ACRO to inform the Agency’s future guidance regarding disruptions of clinical trials in Ukraine, Russia, Belarus and surrounding areas (e.g., Moldova). The Agency also issued guidance related to data and study documentation to date. In partnership with ACRO, Syneos Health will continue to work with the FDA and other regulatory agencies to develop future guidance.
COUNTRY LEVEL UPDATES
- Ukraine: Syneos Health’s priority in Ukraine remains the safety and wellbeing of our employees and their families; we are providing them with financial, logistical, technology and employee assistance support. We will not start any new clinical trials or regulatory submissions and, with very few exceptions, will not conduct patient screening and enrollment activities. Our client support teams continue to work through the impact of the war on each trial and will be in direct contact with sponsors to discuss.
- Russia and Belarus: Our intent in these countries is to maintain project continuity, as feasible, for each active project where we can both protect the rights and wellbeing of clinical trial participants and fulfill study requirements. At this time, we will not be starting new studies in Russia or Belarus, or recruiting new investigational sites for active studies, until we have a better understanding of the impact of the crisis on logistics, supply chain and accessibility to government sponsored hospitals and services.
Recently, the Association of Clinical Trials Organizations (ACTO), which represents CROs and pharmaceutical companies in Russia, issued guidance about conducting clinical trials in the country. Their guidance reaffirms Syneos Health’s approach of pausing all new clinical trials and following a risk-based approach in the country is the current recommended pathway.
INFORMATION AND CYBERSECURITY
As noted in previous Business Continuity Pulse Updates, Syneos Health takes information security seriously. We continue to focus on protecting information and cybersecurity, and maintain administrative, physical and technical safeguards that are designed to protect the confidentiality, integrity and availability of client and corporate data. Syneos Health utilizes 24x7 event monitoring and response capabilities that are designed to detect security events and maintains a corporate response plan to investigate observed events.
BUSINESS CONTINUITY PLANNING CADENCE
We’re regularly updating our Ukraine Resource Center. Please visit our Resource Center to learn more.
Thank you for your partnership during these times of crisis.