Company insight
Stay ahead of the ancillary supply chain
A lack of correct ancillary supplies can be the difference between a clinical trial starting on time or having to delay at significant cost to the sponsor. The Covid-19 pandemic exacerbated what would already be a difficult task of sourcing and purchasing trial equipment. Ancillare CEO Joanne Santomauro explains how the situation developed and how her company stayed ahead of the curve and minimised the impact of shortages in the supply chain.
How did the pandemic affect the provision of ancillary supplies? Joanne Santomauro: At the beginning of the Covid-19 crisis, the sudden demand for critical supplies (needles, syringes, caps, IV lines, thermometers, and more) put immense pressure on the global supply chain. Large quantities of these supplies were needed to meet the immediate needs of healthcare systems with an influx of sick patients. This led to an unprecedented shortage of ancillary supplies for clinical trials. Well past the initial surge of the pandemic, supply chain interruptions compounded upon each other in the form of border closures and lockdowns, labour shortages, manufacturing delays, and much more. This created a conundrum for clinical research: the traditional process for developing treatments was fast- tracked, while the flow of supplies was significantly hindered.
What elements shaped the changes to supply?
The allocation of shipments to hospitals, clinics, and governments was one of the first factors to affect supply. Then came extended factory lead times, numerous recalls of medical devices, and an influx of counterfeit products – to name a small few. Now, factories are contending with raw material shortages, further extending production cycles and disrupting sourcing strategies. The industry’s accelerated shift towards direct-to-patient operations has added yet another layer of complexity with the steps of kitting, labelling, and documentation.
Clinical Trials Insight /
www.worldpharmaceuticals.net
How have ancillary supply providers adapted to the situation? As a global leader in the clinical trial ancillary supply chain, Ancillare responded as early as possible in the pandemic to minimise interruptions. We learned very early on that forecasting the demand cycle by a minimum of 40% assisted in identifying and allocating supplies to clinical trial sites. We developed numerous stocking and just- in-time programmes to anticipate future need. In the interest of strengthening assurance of supply, our team identified and validated third and fourth tier suppliers, in addition to updating and maintaining KPIs for current critical suppliers. When gaps in factory performance were identified, we had an immediate response programme in place. All this and more meant Ancillare could fulfil 100% of sponsor requests throughout the pandemic.
What are the key ancillary supply considerations in a clinical trial, and how can organisers meet them better than they already are? Ancillary supplies and equipment are inextricable from the regulatory and therapeutic area considerations that affect the rest of the trial (which is why our best engagements begin at protocol development). Working with a supply chain management partner can result in significant time and cost savings by minimising redundancies and maximising buying power. These organisations bring insight not found anywhere else, and consolidate a wide range of functions normally scattered among a host of third- party providers.
It is critically important for the sponsor’s partner to understand the complexities of the marketplace, including regulatory and licensure concerns, standardisation of products and equipment, and comprehensive research. We often say that you can’t buy efficiency from a catalogue. Complex studies demand a singular focus on clinical trial ancillary supply management, and a strong partner will add constant value to your phase 1–4 ancillary programme.
Are there changes brought by Covid-19 that you think will endure and shape the way ancillary supplies are obtained for clinical trials into the future?
Many researchers posit that supply chains are on the road to returning to ‘normal’ in the short term. However, our research is indicating otherwise, and we believe these challenges will continue for the foreseeable future. There has been no other time in the history when turmoil and challenges in the supply chain have exposed gaps in performance, necessitating the immediate modification of processes and procedures. Leaders cannot ease up their diligence in surveillance, oversight, and pre-planning and forecasting activities. They must continue to remain flexible and fluid in their supply chain approaches and avoid becoming complacent. Only by embracing these approaches will success be realised, so that patients across the world may continue to be serviced with innovative and effective cures. ●
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