Clinical Trials Insight
management has become popular over the years in many industries, as it keeps the cost of holding inventory to a minimum. Supplies are only received when needed, but on the downside, it relies on highly accurate forecasting and reliable delivery systems. There is a real risk of stockouts, and the potential to reduce waste and minimise storage costs must be balanced against the potentially high level of vulnerability and uncertainty that comes with this model.
Ancillaries cover an almost endless list of clinical supplies from gloves to glass vials.
The devil truly is in the details. Even with a comprehensive list of the ancillaries required, there may be many vendors to deal with to secure the required supplies, even before inventory issues and logistics have been brought into the equation. With so many complications involved in sourcing materials and equipment that may not be at the top of the list of priorities, mistakes can be made. And this is not a problem that can be solved by just throwing money at it. Trials need to be run as cost-efficiently as possible, and ancillaries are never going to be at the top of the list in planning terms, so they should not start to shoot up the list of major costs. The focus is rightly on ensuring that the study drug is manufactured and ready for shipping, and that the necessary comparators have also been sourced. But this should not lead to a failure in ancillary management because the process has been delayed for too long. Ancillaries are perhaps the least interesting part of the process of designing and planning a clinical trial, so no one is rushing to the head of the queue to take responsibility for them, and the headache that comes with their unique procurement and distribution challenges. But the buck must stop somewhere, so when it does, choices must be made about the relative strengths and weaknesses of different stocking and replenishment models.
Making the model work 8.84%
The clinical trial equipment and ancillary solutions market’s compound annual growth rate. 360iResearch
56
Using average-based forecasting systems in clinical trial supply chain management is one option. It relies on using historical data to predict future demand for various supplies. While this can deliver some clarity, it does lack nuance. It may provide a useful baseline, but the sophistication required for informed, data-driven decisions in complex and dynamic environments is lacking, and it does not reflect the idiosyncrasies of individual trials. The just-in-time (JIT) approach to inventory
A centralised distribution model consolidates the purchasing, storage and distribution of critical supplies at a central location, which offers economies of scale and potential improvements to efficiency. With a central location as the focal point for the coordination in the clinical trial supply chain, it seems simpler to ensure that supplies arrive where and when they are required. With JIT and centralised distribution, however, there is a level of complexity that is hard to address. Ancillaries are so varied and so numerous that potential efficiencies could easily be eroded. Vendor managed inventory offers a way of taking this responsibility out of the sponsor’s hands. A third-party vendor can manage inventory levels at trial sites and co-ordinate the overall supply across all sites. The question remains, however, whether a vendor can monitor and supply all the ancillaries that are necessary. With many options, all with potential drawbacks, what does best practice look like? A growing school of thought is that sponsors would do well to hand over responsibility for all ancillaries to a specialist provider of sourcing services. Such specialists can not only leverage experience in the clinical trials process to understand a trial sponsor’s requirements and navigate regulatory requirements in various jurisdictions but can also shoulder the burden of dealing with multiple vendors to ensure timely delivery. With such a model, sponsors and their clinical supplies teams can focus on their core areas of expertise, including trial design, risk assessment and planning, while the tasks of sourcing and logistics are handed over to third parties. This requires a close and collaborative relationship that must begin well before any trial starts. For sponsors, sourcing and logistics are not core functions, so handling multiple vendor relationships across a potentially vast range of geographically dispersed trial sites would only bring more levels of complexity to an already complicated process. The question with third- party providers of sourcing services for ancillaries, however, is one of trust. Can a sponsor fully rely on an external service provider? The challenge is to find that balance point between cost, control, convenience and complexity. ●
www.worldpharmaceuticals.net
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