At Syneos Health, we continue to closely monitor the ongoing invasion in Ukraine. Our support efforts, driven by our Business Continuity team, remain focused on maintaining the safety and wellbeing of our colleagues, clinical trial patients, investigators and customers.
Recently, Syneos Health met with members of the Association of Clinical Research Organizations (ACRO) to discuss the evolving crisis and response by member companies. During these meetings, we learned that all companies are experiencing similar issues in conducting clinical trials in the region. ACRO members are overwhelmingly aligned in our shared response to focus on the health and safety of employees and strategies for business continuity.
ACRO member organizations are taking similar approaches related to patient recruitment and enrollment, site activation and SSU activities in Ukraine. In Russia and Belarus, member companies are employing one of two approaches – one focused on implementation of a sponsor-derived clinical trial strategy and another where the CRO has recommended and is deploying a risk-based approach. At this time, Syneos Health has opted for a risk-based approach.
One important outcome of the ACRO meeting is the commitment by member companies to share information related to humanitarian efforts, helping ensure the clinical research industry is aligned and speaking with a single voice.
COUNTRY LEVEL UPDATES
- Ukraine: Our focus is fully on Syneos Health employees and their families. Our Business Continuity Team is working nonstop to ease employee concerns, supporting them through financial, logistical, technology and employee assistance. In Ukraine, Syneos Health will not start any new clinical trials or regulatory submissions and will not conduct patient screening and enrollment activities. Additionally, it is highly likely that a majority, if not all clinical trial subjects, will be discontinued from clinical trial participation. Our client support teams are working through the impact this will have on each trial and will be in direct contact with sponsors to discuss.
- Russia: Given the evolving crisis, Syneos Health has updated guidance for clinical trials in Russia. We have instructed our teams to assess each project in a risk-based approach for the conduct of field or remote monitoring visits, and appropriateness for active patients to remain enrolled in a clinical trial.
- We are pausing all new site activatins, screening and enrollment activities in Russia until a thorough risk assessment is completed, working with sites, customers and clinicians to make informed decisions. Our immediate priority is the safety of subjects enrolled in our clinical trials.
- Our intent is t maintain project and patient continuity, as feasible, for each active project. However, the impact of recent sanctions and trial logistics is making this increasingly challenging. While we are able to conduct most critical clinical trial activities in Russia, it is at the discretion of the sponsor to continue their trials as practical. Our teams continue to monitor this situation and raise issues of increasing risk to inform ongoing decisions.
- We will not be placing new studies or recruiting new investigational sites for active studies in Russia until we have a better understanding of the impact on logistics, supply chain, and accessibility to government sponsored hospitals and services.
INFORMATION AND CYBERSECURITY
Syneos Health takes information security seriously. We maintain administrative, physical and technical safeguards that are designed to protect the confidentiality, integrity and availability of client and corporate data. These controls consist of a layered approach and include perimeter, network, endpoint and authentication controls. In addition, 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.
Syneos Health continues to monitor, evaluate and adjust to the banking and economic sanctions on a site by site and project by project basis. If a site or a vendor is with a sanctioned bank, or affiliated with the military or government, we intend to engage with the site or vendor to understand whether they are able to move to a bank that is not subject to sanctions. This engagement will inform next steps.
There are significant disruptions to logistics companies operating within Russia. These disruptions may have a direct impact on clinical trial activities for an indeterminate period of time. We continue to monitor and assess restrictions placed on Russia related to import/export controls affecting clinical trials. We will determine and share next steps accordingly.
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.