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.

Ancillare’s Impact: Our Drive to Reach Further (And Closer)

Ancillare’s Impact: Our Drive to Reach Further (And Closer)

For those of us working every day to support clinical research, we know we are contributing to the greater goal of improving patients’ lives. Many of us entered the industry out of a desire to make a difference for those suffering around the world. COVID-19 vaccines, which offered immediate protection for ourselves and our loved ones, gave us a glimpse at the real world outcomes of our work. But when those outcomes are not visible, we can lose sight of the impact we are making.

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.

Jessica’s Story

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.

Why Our Work Matters

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.

Risk Management in Clinical Trials: How the CTASC™ Approach Strengthens Clinical Supply Chains

Risk Management in Clinical Trials: How the CTASC™ Approach Strengthens Clinical Supply Chains

Minimizing interruptions in your Clinical Trial Ancillary Supply Chain lowers risk of delay in your trial timeline — potentially saving millions in overall trial costs.

The COVID-19 pandemic disrupted the global clinical supply chain. The sudden demand for ancillary supplies for clinical trials like needles, syringes, caps, IV lines, and thermometers put tremendous strain on Sponsors, who were up against the clock to develop safe and effective treatments.

Traditional procurement models could not meet the urgent need for these supplies. The same products needed to conduct vaccine trials were directed to healthcare systems and governments first, leading to unprecedented shortages.

Ancillare’s background of industry-wide innovation made the organization uniquely prepared to address these challenges. And in the post-pandemic environment, with no end in sight to recalls, shortages, and other supply chain interruptions, the CTASC approach offers the best path forward to mitigate risk and avoid costly delays.

The CTASC Blueprint for Crisis Management

Many years prior to the pandemic, Ancillare’s founders applied decades of supply chain expertise to develop the Clinical Trial Ancillary Supply Chain (CTASC™) model. CTASC treats sourcing and managing ancillary supplies for clinical trials as its own discipline, creating detailed protocols to meet any type of supply chain challenge, and going beyond the confines of individual trials to develop program-wide strategies.

Many of Ancillare’s responses to crisis conditions will remain permanent CTASC offerings. For example, during a COVID-19 vaccine trial, Ancillare’s Innovation Team created and delivered customized kits that were equipped with all supplies required for a single patient’s visit. As a result, direct-to-patient kitting will be made available to all Sponsors as a quality assurance measure.

Why Sponsors and CROs Need a CTASC Partner

Dedicated CTASC management has always offered a clear advantage to Sponsors by deriving real-time solutions from long-term data. The COVID-19 crisis put this approach to the test during a period of unusually high demand — and also proved its long-term value for Sponsors.

In addition to working directly with Sponsors, Ancillare partners with Contract Research Organizations to alleviate pressure at any stage of the CTASC cycle. A centralized, strategic procurement option gives CROs a more reliable option for supply and equipment sourcing.

Put Ancillare’s Time-Saving Approach to the Test

We believe that a well-planned Clinical Trial Ancillary Supply Chain is essential to on-time, on-budget trials. Whether for a single upcoming project, or your entire clinical development program, our experts are always happy to discuss strategies tailored to your team’s needs. Schedule a fifteen-minute consultation today.

Dry Eye Syndrome

Dry Eye Syndrome

THE SCIENCE BEHIND THE SUPPLY CHAIN

Dry Eye Syndrome

A Therapeutic Overview by Dr. Georgia Crozier, Medical Director

Dry eye syndrome is a common condition around the globe. There are at least three million people diagnosed each year in the United States. It often occurs as a result of decreased tear production with age.

The symptoms of dry eye are extensive and diverse within the adult population. Common complaints from patients may include burning, itchiness, foreign body sensation, excessive watering, redness, and light sensitivity. When a patient presents with a dry eye, the optometrist may notice changes on the front surface of the eye in the tear film, swollen eyelids, and debris buildup on the eyelashes. In these patients, vision may be reduced and can often improve temporarily with repeated blinking.

Other common causes include refractive surgery, which can create less tear production, as well as the use of medications, such as antihistamines, antidepressants, diuretics, and beta blockers, which reduce mucus production. Links have been drawn to excessive screen use, on a computer or cellphone, as people tend to blink less while using their device. Systemic change in hormones deriving from pregnancy and menopause as well as changes in environmental conditions, such as increased wind and low humidity, are all common causes of dry eye syndrome.

Therapeutic Area

Ophthalmology

Treatment Options

  • Artificial Tears
  • Prescription Tear Stimulators
  • Oral Medications
  • Punctal Plugs

Ancillary Supply Chain Insights

Ophthalmologic studies can vary greatly in supply and equipment needs, depending on the indication being studied. An ophthalmology CTASC looks at:

  • Direct Ophthalmoscope, Occluder, Optical Coherence Tomography (OCT), Pachymeter and other surgical equipment needs
  • the best options for cuffs, scales, and blood draws
  • testing and diagnostic testing equipment
  • organizational materials for study-related documents and IP

Ancillare offers specialized support for complex clinical supply chains. From consultative support such as the Ancillare Innovation Team, to technology resources such as the Ancillare Digital Communications Platform, we help Sponsors navigate the challenges of sourcing and managing ancillary supplies for clinical trials in ophthalmology and all therapeutic areas.

Ophthalmology Experience

36 CTASCs supplied

Ancillary Supply Distribution

22 Depots activated