Company insight


Ensuring uninterrupted clinical supplies during a pandemic


The Covid-19 pandemic has had significant impact and caused major disruption to the clinical trial ancillary supply chain (CTASC), creating many supply chain challenges. Joanne Santomauro, the founder and CEO of Ancillare, discusses addressing these challenges while managing Covid-19 clinical trials during a pandemic.


What are the main clinical supply chain challenges Ancillare has faced during the Covid-19 pandemic? Joanne Santomauro: I probably sound like a broken record saying that the Covid-19 pandemic posed supply chain challenges never experienced in any of our lifetimes. Borders and countries were in complete lockdowns. Commerce all but halted. Patients feared venturing outside of their homes. And, in many cases, clinical trials were paused altogether.


as a result of inferior product being released to the field – all resulting from constraints on factory production systems. Result: the perfect supply chain storm. As the preferred supplier for many of the sponsors who were conducting numerous Covid-19 trials simultaneously, Ancillare needed to formulate a response to achieve success and keep the research moving as fast as it needed to be conducted. But trumping the literal supply chain challenges was the need to


“Ancillare’s approach to CTASC management remains as diligent as in the first months of the pandemic, so we can continue to be as responsive, if not more so, post-pandemic.”


Add that to the immediate and critical need for clinical trial ancillary supplies required to conduct Covid-19 trials, such as needles, syringes, caps, IV lines, thermometers, for example, and we quickly experienced extreme pressure on the supply chain. All supplies were in extremely high demand, among hospitals and healthcare systems trying to provide critical frontline care. Governments and hospitals were first in the factories’ lines of production to receive shipments. And requests for medical devices and equipment also simultaneously surged. In addition to these unprecedented challenges, counterfeit product flooded the supply chain and numerous manufacturers were issuing recall notices


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maintain the physical and mental health of our essential workers, our colleagues at the sponsor companies and our remote teams. Managing clinical trials, especially the Covid-19 trials, involved demanding, difficult work. Ancillare team members embraced the mission fully. Watching our teams maintain focus through impossible conditions, finding motivation alone in knowing that our work was touching the most critically ill patients and their families, was particularly inspiring to me. When everyone in the world was needing life sciences to provide the much-needed treatment and vaccines, I was proud that Ancillare could play a critical role in achieving the most demanding of timelines.


How have you addressed these challenges to ensure uninterrupted clinical trials? Really, it’s the same way we approach all of our clinical trials; through patient- focused CTASC development, flexible supply and equipment options, and to work as a true extension of the sponsor’s clinical team.


When supply is short and demand is high, our clinical development team is able to adapt complex protocols to the supplies and equipment that are most available and able to be sourced, procured, and delivered to sites across the world. Our centralised model of management paired with our decentralised depot network is key to maximising the agility of the supply chain, while never sacrificing quality, responsiveness and, of course, the patient’s needs.


The pandemic created a shortage of ancillary supplies for clinical trials. How was Ancillare able to source ancillary supplies during this shortage? We immediately formed a task force, which included members from across our global organisation. We met daily to discuss the on-the-ground intel we were receiving from our teams, and to proactively identify qualified factories who were ready and equipped to accept large quantity orders (sometimes more than a million supplies per purchase order). As a result, as soon as we


Clinical Trials Insight / www.worldpharmaceuticals.net


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