The Cost of Overlooking Ancillary Supplies in Protocol Development

Contributed by:

Joanne Santomauro, CEO, Ancillare

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Recent upheaval in the global supply chain can no longer be seen through a crisis-control lens. It is a new reality forcing leaders, teams, and entire organizations to fundamentally change their approaches. It is arguable that the impacts are felt most acutely in pharma, where delays carry colossal costs at every stage — both for companies and consumers.

What will it take to overcome grand-scale supply chain challenges, avoid massive business ramifications, and produce the best possible outcomes for patients worldwide?

The answers become clear when considering the broader scope and implications of the life-sciences industry. Innovation is what drives drug development and clinical research.
Ingenuity brings new treatments to market, saving and improving lives around the world every day. But underneath these inscrutable forces are firmly established processes, parameters, and regulations. Deeper still is a commitment to maintain the status quo — for better or for worse. Though a deep curiosity enables the development of new treatments, the same sentiment rarely bleeds into the operational realm. The demarcation between the “why” and the “how” ultimately becomes the biggest inhibitor to innovating clinical trial operations.

Take ancillary supplies as an example. Traditionally, supply and equipment needs are not addressed until site selection and initiation. That is a function of habit, not strategy or innovation. Now, in the wake of a global pandemic, interruptions and delays that once felt like temporary inconveniences are now long-term stoppages across the entire industry. The old process of sourcing and managing ancillary supplies is untenable under such conditions.

Risk Management the Foundation of a Supply Chain Strategy

Any well-planned supply chain is built on a foundation of risk management. Contingency planning helps protect the flow of supplies from the impact of unexpected events and circumstances. When Ancillare anticipated the strain on the global supply chain early in the COVID-19 crisis, its teams took action to secure sufficient quantities of vital supplies. This ensured that vaccine trials would be properly supplied and Sponsors could meet their accelerated timelines.

That level of foresight is now necessary for all trials. Sourcing ancillary supplies should be part of the conversation from the beginning, and protocols should match what the supply and equipment needs will be. When proper planning takes place, pharmaceutical supply chains become less siloed, more predictable, and beneficial to the bottom line. The same innovative thinking that drives the development of new treatments can and should be applied to the optimization of processes within clinical research.

In these moments of flux, there can be an impulse to deal with each challenge individually as it comes. Teams will scramble to find last-minute solutions. But in most cases, the problem could have been identified and addressed much earlier in the process. Accounting for ancillary supplies and equipment early in the trial lifecycle is a key way to prevent catastrophic supply chain interruptions down the line, and can result in tremendous time and cost savings.

Preparedness Matters

The pandemic shed acute light on why preparedness matters. But the real solution to strengthening clinical supply chains goes a few steps further, bringing ancillary supplies back to protocol development and other early stages of clinical trials. Proactive planning takes a holistic view of the individual trial, the sponsor’s entire program, and the ecosystem surrounding it (including past trial data, regulatory factors, and more). Every stage of the clinical trial stands to benefit, and sponsors are far better positioned to continue innovating on behalf of the patient.

Supply chain disruptions are not going away. Entities conducting clinical trials must reevaluate how ancillary supplies fit into their clinical supply chain. And through that process, they may discover strategies that could be saving time, money, and resources.(PV)

Ancillare is the first and only life-sciences company dedicated to Clinical Trial Ancillary Supply Chain (CTASC) for Phase I-IV clinical research. Ancillare has supported more than 4,000 clinical trials across 200,000 clinical sites over 100 countries with a corporate office in the United States, and distribution hubs in Argentina, Brazil, Canada, China, Israel, Japan, South Korea, Mexico, Netherlands, Philippines, Russia, Taiwan, and Ukraine.
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