Best practices: Clinical Logistics Services in Emerging Markets

By: Ying Sin Lee
Manager, Clinical Logistics, Asia/Pacific

Managing clinical supplies in emerging markets

Experienced local resources are vital for successful global logistics

One of the most significant trends in the biopharmaceutical industry in recent years is the globalization of clinical studies.  While this trend has helped the industry accelerate drug development and reduce costs, it has created significant challenges for clinical logistics.  As multinational trials become more common, managing clinical supplies and lab services for studies that can encompass hundreds of sites around the world is increasingly problematic.  

The rapid growth of clinical trials in emerging markets such as South America, Eastern Europe, India, China, Southeast Asia and Africa requires specialized expertise to coordinate logistics and avoid supply-related delays.  As a result, many sponsors are utilizing logistics partners with local, experienced resources and infrastructure to ensure a cost-effective and reliable flow of clinical supplies for their global studies.

One of the key challenges for any global logistics provider is understanding the differences in regulations covering the importation and exportation of study drugs, medical supplies and lab samples in these emerging markets.  Although many of the countries have established regulations that are based on International Conference on Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines, there remain substantial differences and variations that must be accounted for by any clinical logistics provider.  For example, some countries require a special import license or an advance authorization by a designated reviewing agency.  Others limit the quantity of a drug that can be imported for a trial.  Labeling requirements for imported drugs also vary by county.  Even countries that comply with ICH-GCP regulations often have their own rules or processes that must be followed to import drugs for clinical trials.  In addition, import taxes and specific customs processes need to be considered. The regulatory environment is also constantly evolving in these countries as government agencies refine their regulations to accommodate the growth of clinical trials.

Laboratory sample management is another major logistical challenge for global trials.  Biological samples that are being exported are subject to a different – and often stricter – set of regulations than imported trial drugs in most countries.  Blood-related products and genetic material in particular are severely restricted or banned for export by some countries.  Such restrictions can obviously have a significant impact on logistics management strategies for lab analyses and the location of centralized lab facilities.  The timely delivery of samples across borders to analytical laboratories is an additional logistics challenge that must be considered carefully for any global drug development program.

Logistics providers with a presence in the countries or regions where trials are being conducted have a clear advantage for understanding the regulatory environment and licensing requirements in each country.  A provider with long-standing experience and local infrastructure is in a much better position to help sponsors navigate these regulatory issues.  An in-country drug depot, for example, allows a sponsor to store medications and supplies locally – reducing the risk of delays due to importation issues.  Contracts with qualified local labs can avoid issues with the exportation of biological samples.  A provider that has close working relationships with each country’s regulatory agencies can also provide valuable insight to sponsors about regulatory approaches that can speed up review processes and increase the chances for approval.

Because the differences in regulatory requirements in emerging markets can have a significant impact on clinical logistics, they can also affect the costs and timelines for the overall clinical trial plan.  Logistics considerations must be included from the beginning of protocol development for every study that contemplates utilizing site in emerging markets.  The savings for faster patient recruitment and lower medical costs must be balanced with transportation and distribution challenges, regulatory delays and other factors that can increase study expenses.  The volume of drugs being manufactured for a trial is also an important consideration at this early stage, because factors such as product stability, shelf life, and recruitment projections must be carefully analyzed as part of the logistics strategy.  This is even more true for biological products, where the handling requirements may be a challenge in some countries.  The cost of biological substances or add-on/rescue medications can also have multi-million-dollar implications for logistics – making it absolutely vital to avoid oversupply and expiry costs.  These important logistical considerations constitute another key area where companies with specific expertise in global logistics and local regulations can help a sponsor make the right decisions about where to conduct studies to maximize cost and time savings while reducing logistics-related risks.

Successful clinical logistics in emerging markets requires a strong understanding of the local regulatory environment and transportation infrastructure, as well as the available storage facilities at investigational sites.  Given the importance of clinical logistics to the overall success of global trials, it is vital to have an experienced partner, and to include that partner in the earliest stages of clinical development.  The right partner for clinical logistical services in emerging markets can deliver significant value to a sponsor by improving regulatory compliance, optimizing the flow of expensive study drugs, and avoiding delays that dramatically increase the cost of a clinical trial.  Most important, an experienced global logistics partner can give a sponsor greater peace of mind – knowing that the right supplies are in the right place, in the right condition, at the right time.