Clinical Trials Insights 2021 – Stay Ahead of the Supply Chain
As published in Clinical Trials Insight 2021
As published in Clinical Trials Insight 2021
January is Cervical Health Awareness Month. Dr. John Fitzgerald, Medical Director and Subject Matter Expert at Ancillare, shares insights from decades in the women’s health field to raise awareness of cervical cancer and other conditions, discuss the importance of preventive services, and highlight the potential of Decentralized Trials to advance necessary research.
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
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.
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).
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.
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.
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.
As published in DCAT®
Sometimes, we are lucky enough to get a reminder of the tangible impact we make right here at home. Ancillare is proud to celebrate one of those stories from our employee, Jessica.
At age 15, Jessica suffered serious injuries when she was hit by a drunk driver while riding her bike. Her doctors did not immediately realize that she had injured her back. Jessica eventually discovered she had suffered permanent nerve damage, and her pain persisted through adulthood. She explored all options for treatment, only stopping short of opioids to avoid potential addiction.
After decades with no relief, Jessica connected with a renowned neurologist at Delaware Valley Pain & Spine Institute. Dr. Bromberg told her about a device called the Saluda Closed Loop Spinal Cord Stimulator that works by sensing and responding to the patient’s neurological activity. This new therapy, which was developed by an Australian medical device company, was not yet available in the U.S. — but recruitment had just begun for clinical trials in the United States.
Excited to seize the opportunity, Jessica agreed to have the simulator attached to her spine and noticed dramatic relief. She then underwent surgery to have the device implanted, becoming the first American to do so.
Jessica says the device has had a life-changing impact for her and has since stopped all other medications.
Just like each and every Ancillare employee, Jessica contributes to our mission of relieving Sponsor’s Clinical Trial Ancillary Supply Chain (CTASC™) pain points that slow down advancements in medicine. Now, her participation in a clinical trial has given her relief from physical pain that she has endured most of her life.
Our work to make clinical trials run more smoothly helps our partners create hope for patients every day, all over the world — be it through symptom relief, COVID-19 immunization, or the chance to live longer. No matter how small our tasks may seem, we are making a difference.