Operations update on medical logistics and clinical trials

The conflict in Ukraine continues - having devastating consequences for the population of Ukraine and leading to the movement of over 2 million people across Europe seeking safety.

 

COREX Logistics is in daily contact with our employees in Ukraine and offering them every assistance possible.

 

Medical logistics

 

The extremely unstable geopolitical situation across the entire region is presenting significant challenges to all sectors of society and business. Currency issues, border closures, and insecurity in the surrounding countries mean that COREX Logistics is implementing special measures, including alternative route planning (e.g., through hubs including Turkey and Kazakhstan), to maintain the supply and delivery of vital medical supplies to hospitals and patients.

 

Clinical Research

 

The ongoing situation is also having an impact on clinical research specifically early phase clinical trials in the region. According to GlobalData’s Clinical Trials Database both Russia and Ukraine have a significant number of planned and ongoing trials. Analysts at GlobalData argue that disruptions to clinical trials in this region, especially multinational ones, are likely to have a “ripple effect” on the global clinical trial pipeline.

 

In the last few days, the Association of Clinical Research Organizations (AOKI) has published information about its position on conducting clinical trials in Russia. ACTO calls for a focus on the principles of the Helsinki Declaration and the ICH GCP standards, whereby patient welfare and safety are placed above all other considerations. It recommends the following actions:

• postpone launching new projects, opening new sites, enrolling patients in trials which are already underway until the situation has been clarified, if the risks for trial subjects and the organization of the trial processes are high, and also if it is yet impossible to realistically assess the risks;

• consider it acceptable to approve amendments to the protocol concerning patient safety already after taking specific measures to ensure patient safety;

• continue recording all deviations from the protocol, thoroughly and in accordance with the procedure;

• if possible, try switching to working with available laboratories (local or based in countries where biological materials can be delivered), and also, whenever feasible, postpone the collection of biological materials until the logistical issues have been clarified;

• if possible, try to arrange new routes for shipping medicinal products, laboratory kits, other supplies and equipment for trials, during the use of which the transportation requirements can be ensured;

COREX Logistics, continues to monitor the situation and will provide operational updates on medical logistics and clinical trial activities as new information becomes available.

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