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Pharmaceutical Manufacturing and Packing Sourcer

Global Integration

With the globalisation of clinical research comes an increasing need for effective supply chain management, to ensure that a clinical trial can deliver its objectives in a uniform manner around the world. Resources and materials (for example, the product undergoing clinical trial), are often in limited supply, and therefore demands careful logistical planning. The use of data is required to facilitate important management decisions and to best manage precious resources and materials.The information required to support critical decision-making across global supply chains principally includes geographic inventory position around the world, along with inventory status.

There are very few inventory and shipment tracking systems available (and supported) in all countries of the world, and no current instances of consolidation of key logistical data into one common view (to present ‘one version of the truth’). Enterprise resource planning (ERP) systems, which address some of the challenges, are often cost prohibitive – particularly when considering smaller volume global operations, such as clinical trial supply chains (relative to the scale of movements of commercial products), and require extensive modifications as a result.

Geographical Differences

Local infrastructure, such as voltage differences, electric sockets, mobile phone frequency bands and so on, have always shown local variations, and therefore must be adapted accordingly.Different levels of voltage are accommodated through travel adapter plugs, which match a ‘one to many’ plug link to any socket, while ‘quad-band’ mobile phones scan a range of frequency bands to send and receive signals anywhere in the world, allowing the user to remain connected. Adapting different IT applications to easily communicate with each other,however, appears to be more challenging, since the applications on which they are based are often fundamentally different.

While giant pharmaceutical warehouses that move large volumes of marketed drugs on a daily basis may warrant a warehouse management system (WMS), it is often deemed that small volume operations (such as clinical supplies) could be sufficiently well run with a card system or spreadsheet, whereby storage would be found within offices or small controlled areas with limited backup or contingency.These solutions have now been outgrown in developed markets in the face of regulatory compliance and business continuity issues, but can still exist in remote or developing locations. However, development has led to specialist clinical supply depots being adapted to focus solely on managing clinical supplies. Independent ‘local heroes’ have therefore been established over the last two decades within those emerging regions where CROs have pioneered the sourcing of investigators, accessing desired patient populations in a more cost-effective way.These local providers strive to offer specialist services focused on the intricacies of storing and distributing clinical supplies.

Using a spreadsheet soon became a non-viable option for many of the specialist depots. Instead,‘home-made’ IT applications started to be written specifically to manage the unique requirements of clinical supplies.Many were customised Access databases, while others built bespoke systems on SQL or AS/400 type platforms.

These programmes were designed to manage a small independent drug depot that distributes nationally, but the trend towards central management of clinical trials and global consistency of process and information showed deficiencies. As these systems were bespoke, they dealt with the nuances of handling blinded medication with serial and sequence numbers, packaging batches, LOT numbers and so on. Essentially, there were many more levels of product hierarchy than those required by commercially-focused WMS, with a range of planned modifications and workarounds.

In an attempt to gain some global visibility, a few of the large pharmaceutical companies that sponsor global clinical research preferred to put their supplies in their own affiliates’ warehouses, or trust local pharmaceutical distributors to manage their supplies.The trouble with this approach was that although a WMS was used in these larger warehouses, they often did not support the specifics of managing investigational medicinal products, particularly blinded medication serial numbers. Modifications to large warehouses’ WMS were often deemed too expensive and risky to be worthwhile, which led to additional manual process steps needed to locate and manage clinical trial materials.

With multiple bespoke systems, using different operating and data platforms, compounded by WMS only being partially used to manage inventory (supplemented with manual workarounds), most organisations shied away from undertaking a complex integration project to design a ‘universal adapter’ to link the data, with one application, and indeed one worldview of ‘the truth’.

‘Just in Case’Materials Management

As clinical research became globalised, an increasing number of drug depots were needed in emerging markets to accommodate the expansion, and in many cases this was accomplished with local country depots.This resulted in numerous stock locations (as many as 80 or 90 for some major pharmaceutical companies). In the absence of an accurate picture of inventory-level data across the world, the chosen risk approach to mitigation became to overproduce medication and over-distribute throughout the supply depots to meet perceived lead time requirements.Not having a drug available for a recruited patient was a key measure and a more expensive failing than writing off expired products in both investigator experience and trial measures.The supply strategy therefore became to over-stock depots in a ‘just in case’ fashion, irrespective of patients recruitment performance, a strategy that often results in substantially more medication going to waste and more than twice as much overage.

To create any kind of inventory or logistical data, each country depot (or affiliate) would need to run a bespoke report; more often than not this would be supplied in different formats that would need to be consolidated into some form of tangible data on which to base critical decisions. If, for example, 20 depots were being used in a large Phase 3 global clinical trial, one would need to chase up and verify that all the data was sent at a same point in time and consolidated into a single format. This does not represent time well spent by a clinical team, or indeed guarantee accuracy, but there were few alternatives. The result was that real-time decisions cannot be taken to enable a supply chain to be less wasteful.

While interactive voice and web response (IVR/IWR) went some way to addressing these challenges in the eyes of the industry, their level of programming sophistication is often focused on the clinical side of the business, and their medication management functionality often lacks the inventory management functionality commonly seen in standard WMS or any focus on this aspect of the system.

Transport Data

In addition to the limited inventory data, there can be limited transport data too. Just 10 years ago, very few couriers could provide data to track and trace a shipment; often all that could be done to locate a product was to call a customer service centre and trust that they could locate the product, and if still in transit, call the mobile phone of the delivery driver instead. Again, this was time consuming, frustrating and certainly not very robust. Investigators and their pharmacy, however, usually need to know where a shipment is; in most cases, only they can sign for certain medications when delivered. In situations where drugs are in short supply, investigators and monitors can be anxious to know the date (and time) of arrival of the medication to better coordinate patient visits.

Track and trace websites have become the industry norm now, and people are used to checking the status of their shipments (through online milestone updates). An issue does arise when optimising shipping performance and cost-effectiveness as a number of integrators (such as DHL and UPS) and time critical carriers (Quickstat,Marken and World Courier) may be used with different systems. In this case the investigator or monitor may have little information on which courier company’s track and trace system to check, and a phone call to a central management team is all that can be done to trace a shipment. Without an integrated system, it is also difficult for the clinical supply organisation to keep track of shipments. As a consequence, proactive intervention remains aspirational.

Enterprise Resource Planning (ERP)

Some of the largest pharmaceutical companies have decided that they have sufficient global volumes (and risk in their current business models) to warrant the investment cost of implementing a customised ERP system.This involves mapping key data from each WMS or stock system into an ERP tool purposely built for the management and planning of all materials in the supply chain. Few companies have completed their global transformational ERP projects, as it is a colossal task that requires an intensive, collaborative and orchestrated project approach, with the appetite and commitment to see this exercise through.Many major organisations are over 10 years into such projects and are yet to emerge from an implementation stage.

Logistics Integrators

Although ERPs represent one option, they display considerable challenges and rely on stable networks and data flows. Clinical trials management is dynamic, with outsourcing to key suppliers, interactive voice and web response (IVR/IWR) system providers, clinical packaging organisations (CPOs), clinical trial logistics (CTL) and carriers. As a result, providing data integration and consolidated data appears one of the more realistic goals.Global third party logistics (G3PL) companies, also known as ‘logistics Integrators’ have been able to step into this space, since integration of inventory (consolidated depot networks) and information (inventory and transport management) systems is something that they have been doing for many years across all industry segments. As previously mentioned though, clinical supply chains can be far more intricate than, for example, a standard pharmaceutical supply chain with its timelines to study start, country mix and material availability.Therefore, if the task is underestimated, some logistics integrators will struggle to manage the complexity unless they have a number of years of experience within the market.

The obvious way for a logistics integrator to consolidate WMS activity would be to use the same WMS in all the countries where they have depots; this would enable a consistent approach to data gathering, resulting in lower cost integration. In reality, however, many sites are multi-user and with depot networks required to support a global clinical trial ranging from one to 20 (to service 65 countries for example), it is highly unlikely that the logistics integrator would be able to have a footprint in all the countries required. Partnerships with local depots are therefore unavoidable, particularly in emerging economies. This in turn results in integration requirements (either through visibility tools or data replication) and therefore should be assumed to be part of any solution.

Data Replication/Mirroring

To combat this issue, logistics integrators have been able to collaborate with selected providers, with different WMS in different countries, by ‘mirroring’ all global activity into a virtual central ‘global’WMS. All inventory is therefore stored in one WMS that is able to have ‘virtual warehouses’ setup within the data tables. So when a depot shipment has to move from the UK to the US, for example, the products will physically be shipped across the Atlantic, whereas the data is simply transferred in the WMS from the UK assigned inventory location to the US assigned virtual pallet locations.

With all IVR/IWR orders being processed at the central location prior to being forwarded to the actual in-country depots, and these depots confirming the completion of all activities, the global WMS will have a mirror image of inventory that is available at depot. Monthly or even weekly inventory snapshots are used to regularly check inventory balances thus ensuring that the data sets line up.With a supply chain team within the central depot policing the data, ensuring it is being exchanged smoothly and consistently, a global picture can be aggregated into the central WMS.This also allows reconciliation against item response theory where required. Needless to say, the central WMS must be fully validated according to globally accepted standards.With all inventory mirrored into a validated system, the risks posed by some local depots systems not being validated will consequently be reduced.

Large manufacturers using ERPs often prefer integrating into more sophisticated WMS that mirror the global inventory information from around the world, than to build individual interfaces into each local depot. As for smaller organisations, the central WMS is able to provide global data from a single point of contact, which can be particularly helpful.

Visibility Tools

Centrally managed supply chain integration (SCI) and transport management systems (TMS) are also able to aggregate global data; an SCI tool can provide stock, order and consignment tracking, extracting predefined, consistent milestones from the warehouse and carriers track and trace systems.This provides an aggregated view of inventory and shipments taking place around the world (as per the protocol), despite different partners and carriers being used.With the ability to self-serve transport data, rather than calling customer services to find out about a shipment, decisions can be taken more swiftly.The addition of TMS functionality moves this capability to a new level with dynamic carrier selection based upon country, lane, recent performance, costs and product requirements (chilled, ambient, controlled ambient or frozen).


With global clinical trials becoming more complex and demanding more cost-effective solutions using less inventory, transport data will be key when seeking to make accurate decisions.With ‘cost down’ pressure evidently at play, even with the R&D departments of big pharmaceutical organisations, better supply chain management is becoming vital (to remove waste and increase efficiency). The use of different IVR/IWR systems, global supply chain partners and local depots in particular means that aggregation of data from a range of sources is required.

This can be achieved through commercial ERP systems, but for the level of complexity within the marketplace, an integration tool and electronic interface – as provided by a global third party logistics provider focused on clinical trials – seems to provide some important benefits. Correctly done these systems will integrate with the order generation system (IVR/IWR), display inventory, order progress and transport progress, in almost real-time, in order to facilitate management decisions. Case studies where this has been achieved have indicated the following:
  • Cost savings of over 10 per cent of an annual transport budget
  • Single supplier invoicing, giving greater cost clarity
  • Network rationalisation to reduce 50+ global stock holding to a target of 15
  • Ability to allocate all clinical trial logistics charges at a regional and protocol level
  • Resources released for clinical activities, away from materials and logistics management
A further benefit of such systems is the provision of metrics to allow future decisions to be made, even including dynamics decisions on carriers, as well as routings based on up-to-date performance. As a result, there is considerable opportunity for sponsors to use the expertise of logistics integrators and other supply chain partners to drive supply chain visibility and allow access to ‘one version of the truth’. The management of more challenging global studies, against a background of achieving leaner and more agile supply chains, is acting as the catalyst to drive this change.

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Alex Klim is the product manager for DHL Supply Chain’s Clinical Trials Logistics Service (CTL). His previous roles in DHL include implementing materials management programmes in UK hospitals, global depot setups and freight management. Alex has a Master’s in Logistics and Distribution from Westminster University. Email:
Alex Klim
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