Ancillare Answers: How Do You Ensure a Flexible Supply Chain in Times of Global Turmoil?

Ancillare Answers: How Do You Ensure a Flexible Supply Chain in Times of Global Turmoil?

Christopher Calabretta

Global Vice President,
Supply Chain

Matt Dixon

Associate Director,
Supply Chain Compliance
As major world events continue to unfold, every organization is contending with supply chain disruptions. Challenges with Clinical Trial Ancillary Supply Chain (CTASC™) are not going away. Ancillare remains at the forefront of supply chain innovation, and stays committed to helping Sponsors overcome setbacks and achieve their clinical trial milestones.

To provide further insight on how Ancillare addresses these challenges, we checked in with our Global Vice President of Supply Chain and Associate Director of Supply Chain Compliance.

As the supply chain is top of mind for everyone, what are Sponsors most worried about? How do you address their fears?

Sponsors tell us their chief concern is simple: it’s about getting the right product to the right location at the right time. The smallest hiccups in the supply chain can result in massive delays. For us, that means getting involved as early as possible in any given trial. Ancillary supplies and equipment are not always top-of-mind at the protocol development stage. However, we know from recent experience that not discussing the ancillary equipment requirements at the start of the protocol analysis will result in more delays and fewer higher costs. We make that clear for Sponsors when they come to us with big-picture supply chain concerns.

When sites shut down suddenly (due to unforeseen events like Russia’s invasion of Ukraine, a natural disaster, or some other crisis), what does Ancillare have in place that ensures the supply chain does not collapse?

Just like any organization, Ancillare is subject to world events, and in the case of the Russia invasion, following international sanctions. However, we’re able to leverage a vast global network, which includes strategically located depots and long-standing relationships with suppliers all over the world. We will always work to provide alternative paths forward where possible, and to establish secondary solutions in partnership with our Sponsors.

What has Ancillare done proactively to strengthen Clinical Trial Ancillary Supply Chains (CTASCs)?

Many Sponsors come to us looking for stronger risk management strategies, which is why we’ve made it a fundamental part of our process. Ancillare works closely with the Sponsor at the beginning of a project to determine forecasted regions where trials may take place, and we identify suppliers and other partners in those regions that can support the expected activity. Any solution we propose always comes with a contingency plan. We also dedicate time to make fundamental improvements to Ancillare’s category and supplier management strategies, ensuring a more robust and dependable supply chain.

How does Ancillare keep the Sponsor and the sites on the same page when site disruptions are happening?

There are two primary ways we keep communication steady and consistent. First is our single point-of-contact approach. One Project Manager is responsible for coordinating the Ancillare Professional Team™, which includes a wide variety of experts across our Procurement, Logistics, and Quality teams. We hold regular meetings with the Sponsor to keep all parties informed and aligned. Secondly, we have powerful technologies at our disposal to give Sponsors and sites full visibility into what is going on in and around their supply chain. The Ancillare Digital Communications Platform (ADCP) gives real-time updates in a dashboard view, similar to a CTMS. We also deploy Ancillare Alerts to all Sponsors and study teams during times of widespread supply chain disruption.

How does Ancillare support individual sites?

More and more, we are hearing that site management and coordination is a pain point. We take a hands-on, site-centric approach that aims to create a better overall experience for investigators and staff. There are a few key ways we do this:

  • Identify local or alternate solutions for clinical sites as necessary
  • Plan around SIV dates to ensure sites receive all required materials in advance
  • Provide white-glove inside delivery to minimize site involvement
  • Provide clear timelines and tracking information for deliveries
  • Support the site’s closeout activities by recording disposal of materials at the site, or facilitating/arranging reclamation of delivered products as needed

What is one thing Ancillare does better than other clinical trial supply chain management providers?

Ancillare is uniquely equipped to handle emergency situations, including rescue studies. By staying nimble, proactive, and informed, we are able to field virtually any request that comes our way. It’s how we achieved 100% fulfillment over the course of the pandemic, and it’s how we’ll continue to provide innovative solutions for Sponsors amidst supply chain turmoil.

Are You Facing Supply Chain Challenges?

Speak with our experts to get tailored recommendations for your CTASC™.

Know + Know How: Reengineering Consultative Partnerships in CTASC™ Management

Know + Know How: Reengineering Consultative Partnerships in CTASC™ Management

Today’s clinical research environment requires cooperation and insight across countless organizations, teams, and specialists. More and more, Sponsors are turning to trusted third parties with high levels of expertise to make their trials run effectively.

Collaboration often develops into long-term partnerships, which can produce tremendous value. On the other hand, mismanaged partnerships can also spur frustration and dead ends. A common example is the consultative exchange, which often leaves Sponsors with a wealth of advice — but no path to implementation. Without the operational means to execute the strategy, they are back to square one.

The Strategy to Success

To make the most of consulting engagements, Sponsors should aim to partner with teams that not only demonstrate specialized knowledge, but also the ability to put their own advice into action. The difference between the two can be difficult to spot — but probing for anecdotal examples gives tremendous insight. It is always worth the time to ask prospective partners about the types of challenges they have been brought in to solve, and the specific steps they take to arrive at solutions.

Another indicator of an implementation-oriented partner is use of technology. Whether looking at companies of larger scale who offer full clinical trial management systems, or smaller teams with specialized programs and solutions, Sponsors will benefit far more with robust technologies at their fingertips.

Nuances of Clinical Supply Chain Management

Some aspects of conducting clinical research benefit from highly specialized support. Sourcing and managing ancillary supplies for clinical trials is a prime example. There are countless approaches to outsourcing ancillary supply and equipment management, but some will only place greater burden on the Sponsor when all is said and done.

Ancillare developed the Clinical Trial Ancillary Supply Chain (CTASC™) approach for precisely that reason. While Sponsors need to make informed decisions about their clinical supply chains, they also need support to innovate along the way. The consulting component of CTASC is an invaluable resource for Sponsor teams, particularly in the planning and start-up phases. It bolsters risk management in clinical trials, and ensures that protocol considerations do not take a backseat.

Sponsors can also choose to turn over their ancillary supply chain management entirely, reaping the benefits of an end-to-end solution. A fully managed CTASC means no loose ends after the engagement comes to a close — everything is handled, all the way through to returns, reclamation, and disposition.

CTASC™: a Holistic Solution

Ancillare is reimagining what consultative partnerships in clinical research can be. CTASC makes supply chain expertise practical, with hands-on support to bring entire strategies to fruition. Our engagements are flexible, and we work closely with Sponsors to address and relieve unique pain points. To find out how Ancillare can support your team, contact us today.

Clinical Trials Insights 2021 – Stay Ahead of the Supply Chain

Clinical Trials Insights 2021 – Stay Ahead of the 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.

As published in Clinical Trials Insight 2021

PharmaVOICE Supply Chain SHOWCASE: The Cost of Overlooking Ancillary Supplies in Protocol Development

PharmaVOICE Supply Chain SHOWCASE: The Cost of Overlooking Ancillary Supplies in Protocol Development

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?

As published in PharmaVOICE

Prepared vs. Proactive: Is Your Clinical Trial Ancillary Supply Chain™ Supporting Trial Success?

Prepared vs. Proactive: Is Your Clinical Trial Ancillary Supply Chain™ Supporting Trial Success?

As the effects of the pandemic reverberate through global supply chains, Sponsors still face many hurdles in sourcing and managing ancillary supplies for clinical trials. Interruptions and delays that once felt like temporary inconveniences are now long-term realities across the entire industry, and there is no choice except to adapt. But how?

In these moments of flux, some teams scramble to take action. Hurried decisions may take care of supply challenges they are dealing with in that particular moment, but do not solve long-term problems. Others cling to convention, hoping that established processes will maintain structure and familiarity amidst the chaos of delays, shortages, and interruptions. Staying the course has its merits, but still does not address the underlying issue. And when all is said and done, the patient pays the price for every milestone missed.

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.

When in the trial lifecycle are ancillary supplies accounted for? 1. Protocol Concept 2. Protocol Development & Study Analysis - Ancillare 3. Submissions 4. Permissions & Approvals 5. Site Selection & Initiation - most CROs and clinical supply vendors

Different Responses to Change

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. For instance: early in the COVID-19 crisis, Ancillare anticipated the strain on the global supply chain and took measures to ensure vaccine trials would be properly supplied and Sponsors could meet their accelerated timelines.

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 the planning phases of a trial. 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).

CTASC™ as a Business Strategy

Clinical Trial Ancillary Supply Chain (CTASC™) is a key component of a well-planned clinical supply chain. The CTASC model blends proven supply chain strategies, data and technology, and human insight to innovate and optimize in the moment — and over time. Unlike traditional approaches to sourcing and managing ancillary supplies for clinical trials, CTASC is not just about making sure the right item is available and gets where it needs to go. Rather, it is designed to be implemented at the earliest stages, looking at the big picture to identify efficiencies from the start. Sponsors realize significant time and cost savings, and benefit from the operational efficiencies of a single vendor.

Decentralized Trials: Ensuring an Integrated Supply Chain

Sponsors conducting decentralized clinical trials must be able to count on their clinical supply vendors to coordinate necessary items in a highly organized fashion to maintain the integrity of the trial and its data. The CTASC model accounts for the specific configurations needed for the trial’s protocol as early as possible so that supplies are sourced, produced, kitted, labeled, and shipped according to the trial’s timeline. Single patient kits are assembled with precision and consistency for safety, compliance, and data quality.

Ancillare now offers Direct-to-Patient Kitting for global sites. Contact us to learn more.

Clinical Supply Chain Is Changing. Your Strategies Should, Too

Since its founding, Ancillare has innovated on behalf of Sponsors. Now, as the industry adapts to a supply chain forever changed, the ability to think several steps ahead has never been more necessary. Speak with our experts to find out how your trials can benefit from a fully-integrated CTASC.