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Demand-Driven Labelling and Distribution: What It Is and Why You May Need It

The increasing cost, complexity and global scale of clinical research is driving the demand for a more creative and responsive clinical trial supply chain management. These trends have led to an increase in both the range and reach of specialist clinical services and trial supplies companies, many of whom have upped their game to respond to these new demands and emerging challenges. Clinigen CTS, as a global leader in clinical services, is at the forefront of this move with a range of strategic services, including new responsive systems coming on stream this year. Demand-driven labelling and distribution (DDLD) is just one of these services – but how does this work, and how can it improve trial efficiency and save money for study sponsors?

Just-in-Time Solutions


DDLD is a fully developed service, newly added to Clinigen CTS’s portfolio of capabilities and evolved from the needs of clients for a more comprehensive, efficient and global service. The company has worked hand-in-glove with its customers to develop a rapid reaction service, which enables 48-hour turnaround on an order being placed and correctly labelled supplies being delivered direct-to-site. This service can only be provided if stateof- the-art storage and labelling facilities are in place, along with regulatory knowhow, in-house qualified persons and global risk mitigation insight.

Clinigen CTS has developed such a facility and the expert support team to manage it, and can now offer a comprehensive DDLD service to support local, regional or global studies.

Catering to Demand


The principle behind DDLD is underpinned by the strategic sourcing, secure storage and swift distribution to investigator site of appropriately labelled trial supplies, based on specific demand within a study (or group of studies). This specific demand is triggered by actual patient recruitment rates in the centres involved in the trial, and properly labelled stock is rapidly dispatched to the centres as needed.

To take an illustrative example, compare and contrast the old and new (DDLD) approaches to a four-centre trial with an assumed recruitment of 100 patients per centre. A standard approach to supplying such a study would see the production of 4x100 patient packs with all country-specific labelling and study number allocations pre-determined. Each centre would receive 100 packs in the hope that they will enrol that many patients over the time of the trial. In reality, however, it is likely that enrolment rates would vary and some of these expensive investigational medicinal products (IMPs) could be wasted or go past their expiry dates.

On the other hand, a more customised DDLD approach would see the IMP stock held centrally and – apart from a small initial delivery to start the trial – the rest of the material, correctly labelled for that country, would be delivered only when needed. In this way, if one country recruits faster than expected, they will receive more supplies than a more slowly recruiting centre (see full PDF for Figure 1).

Cutting Costs

Furthermore, with DDLD, Clinigen CTS only brings in the material that is needed for immediate DDLD supply – potentially saving clients millions of dollars which might otherwise be wasted on overage, re-work of packs due to local regulatory changes or expired stock. It is a secure and compliant system, where supply and demand are in perfect balance to improve both cash flow and trial efficiency.

The cost-saving benefits can be further amplified by using the DDLD approach beyond IMPs. Non-IMPs, such as rescue meds, concomitant essentials and other standard of care medicines, plus the ancillaries required for administration, can all be brought into the same sourcing and distribution strategy. Clinigen CTS takes care of such requirements with the same market-leading quality standards as it employs with IMPs, resulting not only in efficiencies and significant cost savings, but also mitigating against the risk of stock-outs and any impact on patients’ health.

Perfect Partner


In addition to saving operational time and money, DDLD can have a significant impact on overall study timelines, with all the positive implications this has for longterm return on research programmes and new product development. Furthermore, a modern, well-managed supply chain enhances sponsor reputation with research institutions, principal investigators, study teams and patients. If you deploy state-ofthe- art systems, you will be perceived by your customers as cutting-edge researchers with whom they are keen to collaborate on future programmes.

For more information on the Clinigen CTS DDLD service, please contact: mark.ware@clinigengroup.com

About Clinigen CTS

Clinigen Clinical Trial Services (CTS) are the global leader in the sourcing, supply and delivery of medication and ancillary supplies for clinical research. After the acquisition of Idis Pharma, Clinigen CTS now has unrivalled global reach, strategic expertise and the capacity to meet any comparator supply challenge. Our comprehensive services ensure all quality, regulatory, security and distribution hurdles are anticipated and overcome to leave our clients free to focus on completing vital clinical studies on time and on budget.

www.clinigengroup.com/clinical-trial-services

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