IN PARTNERSHIP
Impacting the comparator sourcing budget Initial budget impact
• Required product • Number of patients • Study duration
• Countries participating • Local vs global sourcing • Batch requirements • Required documentation (CoC, CoE, etc.) • Availability and lead time of comparator product • Expiry date • Acceptance of biosimilars and/or generics
Mid-study budget impact
• Fluctuations in patient recruitments • Protocol amendments • Changes in the supply chain • Drug shortage/challenges with IMP production
The rising need for, and the importance of,
comparator medication used in clinical trials is not just adding new challenges to the supply chain – comparator sourcing (including required percentage to the clinical trial supply budget.
overages in the past, the rising need for comparators and the price of a variety of comparator products make this strategy unfeasible today. Fine-tuning the clinical trial supply strategy,
incorporating forecasting, planning, risk mitigation and engaging and communicating with your sourcing partner at an early stage are essential when preparing your clinical trial budget.
Factors to consider when building your comparator sourcing budget There are several considerations when preparing your initial comparator budget. Some information are controlled by the market, such as marketing authorisation holders (MAHs) and countries that may impose export restrictions. Aspects like drug availability (general
availability, production timelines, etc), local versus global sourcing options and a host of other factors should be discussed with your sourcing partner. There will be a measurable difference in time and cost depending on the options available. The impact must be assessed when planning and preparing your initial clinical supply budget.
Risk mitigation in comparator sourcing Including risk mitigation in your clinical supply
strategy has become common practice and has helped overcome challenges that occur mid-study. It is accepted that risk mitigation will impact your overall clinical supply strategy and the project timeline – but the effect it has on the clinical trial supply budget is often left aside. The impact that mid-study challenges and
associated changes can have on the comparator sourcing budget can be substantial (as well as on the overall clinical trial budget). So, consider this impact when building your initial clinical supply budget.
Building a reserve budget to cover mid-study
changes (especially for the highest cost factors impacting your budget) is recommended as it avoids the unpleasant need to request ad ditional budget.
Overcoming the risks with comparator sourcing is a complex process. So, having the right partner is essential. Working with CSI can optimise your comparator sourcing strategy and ensure high-quality comparators are sourced on budget and on time. While our headquarters are in London, we operate in the UK, Germany, Japan and the US. global network to source comparator drugs from audited suppliers, originators and dedicated wholesalers in Europe, the US, Latin America regulatory compliance.
For more information on our comparator sourcing services, visit
csint.com or email
info@csi.com.
Outsourcing in Clinical Trials Handbook | 49
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