Ukraine-based Dr. Yuriy Lebed explains how his Contract Research Organization navigates global risk and adopts war as an opportunity to reach out to unique patient groups
A real-life story about where global risk meets local opportunity.
In a virtual interview with Dr. Yuriy Lebed, CEO of Pharmaxi LLC, a Ukraine-based CRO, and host Artem Andrianov, CEO of data science provider Cyntegrity on December 5th, Lebed shares his exclusive and compelling story about securing continued access to investigational medicines and treatments for clinical trial patients and victims of war.
While others withdrew, Lebed and his team seized the opportunity to reach out to unique patient groups made possible by the war and successfully kept their sites open. In this challenging environment, his CRO helps war victims by facilitating acute, on-site treatment as part of continued clinical studies.
“As a data science organization that is entirely focused on de-risking clinical trials and their conduct, learning how to tackle the risks that have low probability and a global impact is an objective that has been on our minds since the COVID-19 outbreak. Now we have a unique chance to study crisis management firsthand," says Cyntegrity’s CEO Artem Andrianov.
Once a crisis is in motion, turning it into an opportunity often requires new ways of seeing, thinking, and responding. Lebed and his team are a living example of this unfortunate event by establishing much-needed survival mechanisms to enable their organization to continue its activities, providing life-changing treatments to patients in Ukraine.
Dr. Yuriy Lebed responds, "Hopefully, some ideas that have helped Pharmaxi pass through the darkest days of this war will benefit life science companies. Maybe they will implement some strategies, and it will increase their resilience and resistance to a crisis of any nature."
Recent catastrophic events such as the Ukraine-Russia war and COVID-19 have spotlighted drug discovery, development, manufacturing, and supply chain and exposed the current system’s deficiencies. At the same time, it has given a glimpse of what can be possible today and how ready the system is for innovation, acceleration, and implementation of needed changes around what, how, and by whom global risk is proactively managed.
In parallel, the digital revolution has increased the availability of data, degree of connectivity, and speed at which decisions are made. Digitization offers transformational promise but also comes with the potential for large-scale failure and security breaches, together with a rapid cascading of consequences.
Lebed and Andrianov discuss an outlook on the expanding horizons for risk management in pharma – solving tomorrow’s problems with today’s data, technology, and expertise.
Register for the webinar at: https://next.edudip.com/… how-cro-ceo-dr-yuriy-lebed-mitigates-a-war/1857820
About Pharmaxi LLC
Pharmaxi has provided high-quality clinical research services to sponsors for more than five years. Its history covers successful program management and support to biotech, pharmaceutical, and medical device companies across all Phases (I-IV), services, and locations (North America, Central Europe, and CIS countries).
Pharmaxi successfully performed over 20 studies spanning 10 countries and has provided integrated key clinical research services for these projects, including protocol development, site selection, project and site management, monitoring, (e)CRF development, database development, data management, biostatistics, pharmacovigilance, regulatory support, and medical writing.
Pharmaxi works with the State Expert Center and the Ministry of Health of Ukraine to create new legislation regulating low-interventional studies. Its experts are also involved in consulting activities for governmental departments linked to developing eHealth services in the country’s frame. These two activities provide independent evidence for our deep expertise in clinical trials and the development of specific electronic services.
Cyntegrity is a leading intelligent risk-based quality management solutions provider in the BioPharma industry. The innovator is proud of its bespoke and highly rated MyRBQM® Portal and MyRBQM® Academy brands.
Cyntegrity supports sponsors, CROs, and auditors with data science technology and related educational programs to focus clinical operations resources on the locations and activities where they are most needed.
Cyntegrity is a fast-growing scale-up company staffed by an international team of industry experts. Today, its team represents 17 nationalities living in 14 countries.
Cyntegrity strives to become the first-choice provider of AI-driven SaaS and PaaS solutions for ICH GCP E6(R2) and E8(R1) compliant clinical trial risk management and risk-based regulatory oversight and surveillance.
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