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Clear Observation

Can clinical trial costs and time to completion be reduced by adopting supply chain visibility tools? Experience shows us that they can, but uptake appears to still be relatively low. So what are the barriers preventing wider usage of supply chain visibility tools and how can they be overcome in practice?

A reliable supply chain can make or break the success of a clinical trial, but why isn’t maximising efficiency a focus for many pharmaceutical companies? Ensuring patient enrolment is, of course, a more pressing concern than the inventory, and this can lead to sacrificing efficiency and flexibility in the supply chain in order to minimise the risk of not having the treatment available at the investigator site when needed. Also, many companies are under the misconception that implementing a more responsive supply chain will require a significant investment in terms of time and money that will not deliver the expected benefits.

In the first instance, the supply chain might not be considered a hugely important factor in clinical trials success, but when you start to consider the huge costs involved in moving investigational medicines across the globe, and the need to account for all returns to complete the trial, it is possible to appreciate how a supply chain that isn’t operating at maximum efficiency can result in clinical trials taking longer and costing more than they need to. In this case, any technology which can claim to make significant cuts to the time and money spent on clinical trials demands closer investigation.

Supply chain visibility tools are one such technology. Implementation of these tools can return significant reductions in both study duration and costs. Based on previous experiences, reductions to distribution costs by 50 per cent and inventory costs by 40 per cent are typical when visibility tools are used in conjunction with network optimisation. However, research has shown that the uptake of this technology has been slower than expected among pharmaceutical and biotechnology companies within their clinical trial programmes. Research also suggests that the reasons for this are largely built on misconceptions regarding the difficulty and costs involved in implementing these tools and the complexity of using them. Given the potential return on investment involved, it’s time that the decision makers within clinical trial functions looked again and asked themselves whether they are really getting everything that they need from their supply chains in order to compete.

What is Supply Chain Visibility?

Supply chain visibility is the ability to know at any one time the location and status of the total clinical trial inventory – where all supplies of the medicines under investigation are, approximate timings to move them throughout the supply chain and additional information, such as how they are packaged or labelled and when they are due to expire. This can include investigational medication, returns, ancillaries and lab kits, although the focus of this article is medication.

Why is this Important in the Clinical Trial Setting?

The benefits of improved visibility are a more responsive supply chain, especially important in a clinical trial setting with limited supplies of experimental stock, as well as the critical importance of having enough to meet supply in various locations. Clinical trials are critical for the ongoing success of any innovative pharmaceutical or biotechnology company, and it is perfectly understandable that companies feel that getting the supply chain to operate at maximum efficiency is not as high a priority as other aspects of the clinical trial programme. Instead, the most important concern is making sure that investigational medicines or treatments get to patients when they are needed. In order to ensure that this happens, clinical trial supply chains are often ‘front-loaded’; that is, a lot of stock will be pushed through to the end of the chain without a clear idea of how much is actually required.

The end result of this approach is that the supply chain becomes bloated and inefficient. It takes longer to respond to changes in demand, and it takes longer for unused stock to be returned or redeployed, thus increasing the associated costs. Often this results in additional manufacturing/packaging activities, increasing overall cost further.

This is often seen as a small price to pay in order to ensure that the trial runs to protocol and timelines, and is accepted as a necessary evil. While in the past this may have been the case, these days updated technologies allow us to be much more sophisticated and get our supply chains to work harder and smarter. Research shows that the benefits of supply chain visibility are well understood. So why are they not being used as much as we would expect? Research commissioned by DHL and conducted by the agency FreshMinds looked into why pharmaceutical and life sciences companies were not using these tools more in clinical trials, and three key themes emerged:

  • Concerns around data collection – information related to the supply chain may be collected in different ways and at different levels meaning that confidence in any system being able to offer true visibility is low
  • Inefficient working practices – the theoretical benefits of supply chain visibility are thought to be unobtainable in practice due to realities on the ground, including the sheer number of stakeholders
  • The misconception that the technology is expensive – aligned to this is the belief that, although inefficient, current processes are functioning adequately enough and there’s no great urgency to improve them All of these are reasonable concerns although, as the case studies demonstrate, we have seen companies implement these tools and make real cost and time savings. So how have they done it?

Simple Steps to Success

The simple truth is that some ways of doing things will have to change if the benefits of supply chain visibility tools are to be realised in a clinical trials setting. This doesn’t have to be a huge undertaking, and the simple steps listed below might help companies to consider how they could benefit from upgrading their clinical trial supply chains.

Move Towards a Standardised Method of Data Collection

This isn’t as painful as it sounds. Most clinical trial supply chains involve a lot of logistical data being generated, collected and used. For example, data regarding transport management systems, warehouse and order management systems and so on, is all generated. The data received centrally is only ever as good as the data captured locally, and so if this is not being done in an optimal way, there are clear limits over what can be achieved in terms of supply chain visibility, flexibility and responsiveness.

If current systems are using disparate information capture systems, consider switching to a standardised model. A good example is using online forms to capture information across the supply chain, which can then be collected in one place and converted into an easy-to-read format. As soon as you show people that data can be aggregated in one place, then see the benefits this could bring.

Improve Communication Between Teams

This will help them to learn from each other. It’s easy to lose sight of the number of stakeholders involved in clinical trials and how disparate they can be. Modern clinical trial programmes taking place in many countries involve a lot of people working together from around the world, which can make managing an efficient supply chain a real challenge.Different decisions made at different locations can affect the overall supply chain. Regular communication between teams is essential if any lessons learnt are to be shared during the trial rather than at the end, or even worse, not shared at all. Supply chain managers should be involved at all stages of the process to ensure that important logistical needs, including customs and regulatory issues, are not overlooked.

Expect More from your Supply Chain

Time and money invested in making the supply chain more efficient is likely to see significant returns. As more companies adopt supply chain visibility tools, the benefits, become more apparent. Companies have seen a concrete return on investment and increased flexibility when they have upgraded their clinical trial supply chains. Taking a view of the industry and the competitive nature of healthcare technology research, it is very likely that supply chain visibility technology in clinical trials will have become the norm by 2015, rather than the exception that it is today.

Further reading

Selected case studies and the findings from the research carried out by FreshMinds can be accessed at www.dhlsupplychainexperts. com/home/life-sciences

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Jonathan Blamey is Vice President of Global Product and Account Leader for DHL Supply Chain’s Life Sciences and Healthcare sector. In his current role, Jonathan is responsible for global clinical trials and hospital logistics expansion. He has worked for DHL Supply Chain in various positions since 2004, serving as Vice President of Product Development for the Technology and Healthcare sectors and General Manager of Clinical Trials Logistics, before taking on his current role in 2007. Jonathan holds a PhD in Biomedical Engineering from the University of Durham. He has also completed an MBA at Lancaster University and holds an MSc in Materials Science and a BSc in Engineering.
Jonathan Blamey
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