Clinical trials in Ukraine: a first-hand perspective
In this update on conducting clinical trials in Ukraine during the war we review:
A country under martial law: operating during the war and what this means for clinical trials
The impact of the war on the clinical trials market: data and anecdotal evidence
Oximio in Ukraine: our people, operations and the services we can solution
Working in partnership to prioritise patient care: Adaptability of service, prioritising shipments, factors influencing cost to serve
A case study: How alternative solutioning has enabled patients to continue on trials
Clinical trials in Ukraine – current status and new growth opportunities
In this update we review:
- The Ukrainian clinical trials market: Current situation and challenges for the industry
MoH activities: Supporting the Ukrainian clinical trials market
Oximio business continuity plan: Overcoming operations disruptions
Regulation updates: Expanded Access Programme regulations in Ukraine
Expanded Access Programme: New opportunities to support local patients
New Oximio solutions: Enabling sites and investigators to focus on their patients
Clinical trials in Ukraine – overcoming disruption
Protocol deviations, trial redesign and contingency planning are all realities for sponsors running clinical trials in Ukraine during the war. Disruptions are unavoidable, for example when scheduled study visits cannot take place, or arrangements need to be made to transfer trial participants who are fleeing Ukraine, to sites in a different country.
Adaptations are required to protect participants’ privacy and treatment regime, including the continuation of ongoing dosing if possible, as well as preservation of data quality generated by the studies.
Despite these disruptions, sponsors and their clinical trial supply chain partners are ensuring that ongoing studies are progressing, and that the processes and infrastructure are in place to resume new start-ups.
Agenda:
- The Ukrainian clinical trial market: current situation
- Regulation updates: Recommendations from Ukraine’s MoH State Expert Center
- A first-hand account of the challenges of clinical trials from stakeholders
- New solutions for overcoming disruptions in Ukraine
- Q&A session
Reshaping the Clinical Supply Chain in sub-Saharan Africa
In a recent webinar, Rob van den Bergh, Regional Director for Oximio, sub-Saharan Africa, shared his insights into the groundbreaking initiatives that are reshaping the clinical supply chain landscape in Africa. Launched with the opening of Oximio Kenya in 2021, these initiatives are designed to tackle the unique challenges faced by the region.
Sharing the stage were Priya Nair, Senior Analyst at Global Data who provided an overview of the current state of clinical trials in Africa illustrating the number of trials, main therapy areas and sponsors. Adriaan Kruger, Co-Founder and CEO of nuvoteQ, providers of software products designed to empower clinical and pharmaceutical research organisations, explained how these were being used to digitalise the regulatory landscape in Africa.
Key Highlights:
- Overcoming Challenges: Insights into the major hurdles – from infrastructure to regulations – that have historically constrained the clinical supply chain in Sub-Saharan Africa, and the innovative strategies implemented to address them.
- Oximio’s Role: Learn about Oximio’s pivotal contribution to reshaping the clinical supply chain through the establishment of Oximio Kenya in 2021, marking a significant milestone in expanding healthcare logistics across the continent.
- Impactful Analysis: Exclusive analysis from GlobalData on the growth of clinical trials in Sub-Saharan Africa, highlighting advancements in women’s health.
- Key Strategies: Detailed discussion on how to reach broader patient populations, optimise resources, and the critical importance of customs bonded depot and Importer of Record (IOR) services. Plus, the art of building essential collaborations for success.
Webinar Q&As
Download a pdf of the webinar Q&As.
Oximio in Africa
For further information on Oximio’s operations in Africa, including eBook and whitepapers, visit Oximio, Africa.
How to Navigate the Complexities of Importer of Record Services in Clinical Trials
The Importer of Record (IoR) plays an essential role in the clinical supply chain, helping products arrive at their intended destination on schedule. However, the area is rife with complexities as regulations vary in different regions and countries. Any documentation errors can have serious consequences for products, clinical trials, and patients. When it comes to IoR, it is crucial not to try and go it alone – even if you think you have everything covered on paper. Ensuring smooth passage requires specialist knowledge and experience.
In this webinar, Zayheda Khan, Oximio’s Chief Commercial Officer and Mark Woolf, Chief Strategy and Development Officer will be providing useful insights on IOR best practices and how to identify the main pain points. Throughout the course of the discussion, we will learn why complexities don’t necessarily have to mean delays. We will also cover real-world examples of common mistakes in IoR and how to avoid them to prevent delays to your clinical shipments.
IOR Key learnings:
- Understanding the role of IoR
- How to ensure compliance with requirements
- The importance of partnerships across borders
- Dos and Don’ts
- Challenges + examples
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