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Why Regulatory Expertise Is Critical to the Healthcare Supply Chain

Moving a vial of medicine or a bottle of pills from point A to point B is a lot different than transporting virtually any other type of product. Not only are pharmaceutical goods and biological materials typically highly sensitive, requiring strict packaging and transportation conditions, but they’re also subject to a range of complex regional and local regulations. This makes it essential for shippers to have regulatory expertise on their side in order to prevent delays, mitigate the risk of noncompliance, and keep the healthcare supply chain moving smoothly.

The high price of import delays

Whether it’s a clinical trial transporting investigational drugs to the testing site or a pharmaceutical manufacturer sending life-saving medicines to pharmacies and hospitals, clearing customs in a timely fashion is critical to the success of any life sciences or healthcare supply chain.

Even the smallest delay can have huge consequences. Time- and temperature-controlled drugs can deteriorate or expire while sitting at the border, resulting in costly waste and, potentially, risk to the patient. Procedures can be postponed because vital drugs and equipment didn’t arrive in time. Freight can wind up quarantined because the proper paperwork wasn’t filled out—and, in some cases, may even be destroyed.

Navigating the ever-changing landscape of global regulations

To avoid issues at the border, shippers need to have a clear idea in advance of what the customs process will look like for any given shipment, and what they need to do to expedite clearance. This can include paying appropriate duty fees at the right time, double-checking that products are classified correctly (particularly dangerous and controlled substances), and ensuring documentation is properly prepared and included with the shipment.

Of course, developing an effective and efficient customs clearance strategy is only possible if shippers have a firm understanding of global regulations. This is easier said than done: customs requirements can be incredibly complex and confusing, and can vary dramatically from one region to the next. And since they’re always changing, it’s necessary to constantly monitor changes and adjust the strategy accordingly.

As such, it’s often a better use of a shipper’s resources to work with a logistics provider with regulatory expertise already and stays on top of changing regulations, rather than tasking staff with figuring out what needs to be done. In an industry as heavily regulated as healthcare—and with so much at stake—there’s little room for mistakes, and it really is better to be safe than sorry.

Supporting the healthcare supply chain

At CTSI-Global, we combine decades of logistics experience with a deep and nuanced understanding of the healthcare and life sciences space. Having worked with some of the leading players in these industries, we understand just how challenging it can be to navigate global regulations—and what it takes to move pharmaceutical and biological products safely, efficiently, and compliantly. We stay on top of regulations so you don’t have to, helping to mitigate compliance risks and prevent detrimental delays.

Find the expert support you need to smooth out every regulatory kink. Partner with us today.

The Rise of the Demand-Driven Healthcare Supply Chain: What Logistics Managers Should Know

As the needs of patients and healthcare facilities have evolved, the healthcare supply chain has undergone some major changes in the past few years. One trend that is only likely to accelerate in the coming years is the shift away from stockpiling and toward a more agile, demand-driven approach to ordering.

Here’s what shippers need to know about this trend—and some steps they can take to prepare.

Stockpiling has proven harmful and inefficient

For non-perishable materials and those that have far-off expiration dates, it was once common for departments to order in bulk and squirrel supplies away for when they were needed. But this had unwanted consequences: supply closets became cluttered and unmanageable, forcing busy nurses to spend hours every week managing supplies. And since some of this equipment was never ultimately used, facilities not only wasted resources in purchasing it, but in storing it, too.

Recent events led to even more stockpiling—creating new and even more troubling problems. In the midst of a global pandemic, some facilities were left facing supply chain shortages and critically low supplies of essential materials, while others acquired a surplus. And with fewer elective surgeries taking place, other materials that had previously been bought in bulk were left sitting in supply closets gathering dust.

For many, these events have been something of a wake-up call. Healthcare facilities are recognizing that they need to be open to making smaller, more frequent orders—meaning shippers will need to prioritize agile, reliable service if they want to keep their business.

Expiration dates are growing shorter

The trend away from small molecule drugs and toward biologics and other complex, large-molecule pharmaceuticals is also forcing healthcare facilities to think more strategically about when and how often to order stock.

Since these modern drugs tend to be more unstable and sensitive to external conditions, they typically have shorter shelf lives and require significantly more stringent storage conditions. As a result, overstocking can lead to costly waste, making it imperative that departments order just enough to meet short-term patient needs and no more.

Of course, supply shortages can cause just as many problems, sometimes even resulting in canceled procedures, and patients left waiting for the care they need. This means that purchasers will demand more from shippers—more control and visibility into the temperature of vehicles, more peace of mind around safety and compliance, and more precision and efficiency when it comes to delivery slots.

Supporting a demand-driven healthcare supply chain

The shift toward a demand-driven healthcare supply chain puts more pressure on shippers. Here are a few steps logistics managers can take to prepare—and continue exceeding clients’ expectations:

Develop a robust list of trusted carriers to ensure shorter lead times can always be accommodated
Ensure carriers with cold chain and cryogenic capabilities can accommodate increasingly complex shipping needs
Take advantage of less-than-truckload (LTL) shipping options to reduce transportation costs for smaller orders
Utilize a high-quality transportation management system (TMS) to rapidly identify optimal freight options
Stay on top of supply chain data to improve forecasting and identify opportunities to increase efficiency

CTSI-Global is strategically positioned to help shippers in the healthcare and life sciences space optimize their supply chains and adapt to a demand-driven market. Reach out to us today to discuss your needs.

Why Reliable Supply Chains Are the Backbone of Clinical Trials

Without clinical trials, potentially life-saving drugs, therapies, and other medical and surgical interventions would never reach patients. But if they’re not backed by reliable supply chains, these trials might never get beyond their initial phases.

Unfortunately, managing the clinical research supply chain is growing more difficult every year. As a result, researchers and supply chain managers need to work together to anticipate potential challenges before trials get underway—or else risk costly and time-consuming setbacks.

Specialized delivery solutions are essential to maintain compliance, ensure product integrity, and protect patients

As clinical research advances and investigational products grow more sophisticated, increasingly specialized delivery solutions are required for transporting products and materials safely to testing sites.

For example, the rise in biologic active pharmaceutical ingredients (APIs) has driven a greater demand for light- and temperature-controlled trucks due to the sensitivity of these materials. Many cell-based products even require cryogenic conditions in order to perform optimally throughout clinical trials. And since clinical trials are subject to Good Distribution Practice (GDP) and Good Clinical Practice (GCP) regulations, the transportation, handling, and storage of all products are subject to close scrutiny.

This poses a challenge for supply chain managers since many commercial carriers cannot accommodate such stringent requirements. Carefully vetting carriers is critical to both the success of the trial—and patient safety.

A nimble approach is required to prevent costly product overages

As pharmaceutical research trends toward biologics and large molecule APIs, researchers and supply chain managers are under increased pressure to conserve investigational products and reduce waste. These materials are not only more expensive and difficult to produce in large quantities than small molecule products, but have shorter expiry dates, are less stable, and require more complex—and therefore expensive—shipping solutions.

While researchers might once have ordered in bulk and saved excess product for future campaigns, it’s now imperative to order the right amount at the right time to ensure it doesn’t expire or go to waste. This is complicated by the unpredictable nature of clinical trials, with some participants dropping out before the trial even gets underway, and numbers continuing to thin as studies progress.

To prevent overstock while still ensuring they have enough product to meet patient demand, supply chain managers need to get more nimble with their planning and purchasing, making adjustments on the fly rather than setting plans in stone months before a study begins. For this approach to work, however, they must have confidence that their carrier network is up to the task of delivering materials on time and in optimal condition—otherwise, trial delays are inevitable.

The smallest disruption in the supply chain can greatly impact a trial’s results

While demand-led planning can prevent costly overstock, it can also leave clinical supply chains more vulnerable to disruption. Having too much product is an expensive problem, but having too little can result in data becoming invalidated if patients miss even one dosage.

To bolster their supply chains and prevent broken links from sinking entire studies, supply chain managers need to engage in strategic comparator sourcing and plan for any eventuality. If a product is being shipped internationally, are there local suppliers that could meet demand in a pinch, or vice versa? And if so, are there alternative carriers on hand that could move that product in a safe, timely, cost-effective, and compliant fashion?

Supporting clinical trials, fueling transformative research

At CTSI-Global, we understand the challenges of clinical trials—and the possibilities. That’s why we’re dedicated to helping teams navigate the complexities of the clinical supply chain to bring the future of medicine one step closer.

Through our proprietary technology, deep industry relationships, and decades of expertise, we can help supply chain managers to quickly identify the logistics solutions that meet the exacting needs of their studies. Our 20,000-strong global network of fully vetted carriers includes major cold chain operators with vast experience moving short-dated and highly regulated clinical materials, so you can feel confident about finding capacity, no matter how sensitive an investigational product is.

Strengthen the backbone of your clinical trials. Find expert logistics solutions and supply chain support by contacting CTSI-Global today.

The Biggest Trends Shaping the Future of Healthcare Logistics Management

The healthcare industry moves rapidly, putting pressure on healthcare logistics managers to stay one step ahead of evolving needs.

Keeping one eye on emerging trends can help. Here are some of the biggest trends we’ve seen shaping the industry in recent years—and the ones we see continuing into 2021 and beyond.

Value-based care and cost management

As more healthcare organizations move away from a traditional fee-for-service model and toward a value-based care model that ties reimbursement to quality of care, cutting extraneous costs will be essential to protecting margins. Value-based care is ultimately beneficial to the end-users, patients—but bankrupt hospitals and clinics can help no one.

Logistics data is often a goldmine of potential savings. However, to unlock them, healthcare companies need to equip themselves with analytics tools and ensure they have no blind spots in their data. With a complete picture of their spend, healthcare logistics managers can more quickly and accurately identify and eliminate waste and tighten efficiency.

Visibility and control

Product integrity is everything in the healthcare industry. In the pharmaceutical supply chain, the smallest fluctuation in a temperature-controlled truck can result in a drug losing its effectiveness—or turning deadly. At best, this can result in thousands of dollars of waste when drugs and therapies need to be discarded. But if the problem went unnoticed, lives could be at risk.

This challenge has led to a demand for reliable, real-time tracking and monitoring solutions to ensure safety protocols are met. Looking ahead, this demand will only increase, with the number of pharmaceutical products requiring cold-chain and even cryogenic conditions rising every year.

The good news is, advances in technology are making total visibility easier to achieve. Where a logistics manager may once have needed to call a driver for updates, vast amounts of data can now be communicated digitally in a fraction of a second—and the technology is only going to get better moving forward.

Resilience and flexibility

Recent events have spotlighted the necessity of building flexibility into healthcare supply chains to bolster their resilience. When the global pandemic hit, countless supply chains were disrupted, impacting the delivery of everything from pharmaceuticals to personal protective equipment. While delays are unwelcome in any industry, in healthcare, they can put lives at risk, making it crucial for supply chain managers to find timely solutions when the worst happens.

Even after this current crisis is in the rearview mirror, flexibility will remain essential. Climate disasters, acts of terror, and geopolitical conflict remain disruptive forces in the world of logistics—compounded by the challenge of ever-rising shipping costs. Advanced data analytics and intelligence give healthcare supply chain managers the tools to proactively evaluate where their vulnerabilities lie and identify alternative options, enabling them to make rapid pivots when a roadblock appears on the path ahead.

Healthcare logistics solutions for a volatile world

At CTSI-Global, we’ve spent decades helping leading healthcare companies streamline and optimize their logistics operations, so we understand the challenges facing the industry—and the opportunities. We follow the latest developments in the industry closely and keep a pulse on emerging trends, ensuring we can continue delivering the solutions our clients need—at the time they need them the most.

Prepare for anything. Contact CTSI-Global today.

The Advantage of a Global Partner in End-to-End Logistics Solutions

Full capacity means access at any time to end-to-end solutions for managing your supply chain from procurement to payment. Think of capacity as best represented by an ecosystem of logistics functions. This is a case for CTSI-Global’s ecosystem, which we call Total Logistics Technology + Intelligence:

Why End-to-End Logistics Capacity Matters

Ultimate Flexibility

A logistics ecosystem allows you both a customized solution and to seamlessly add services to handle any logistics need as it arises, with a reduced implementation timeline.

Truly Global Capability

Because we’ve got people on the ground globally (offices, not just a phone number), you can scale across the entire supply chain.

The Bottom Line

An ecosystem of logistics services affords any shipper an ecosystem of benefits:

End-to-end solutions to manage your supply chain (from procurement to payment)
Carrier agnostic for full transparency & good faith
Best-In-Class TMS, FAP, BI, & staff augmentation
Seamlessly add services as you go
Significantly reduced implementation timeline
Ability to expand your operation globally
Scale and reduce headcount as needed
Customized solutions to meet specific needs
Add carrier capacity as needed (20k carriers)

Compare CTSI-Global to the Competition

Other logistics providers cluster around a single domain of operation and try to fit third party services under the banner of a seamless solution. With them, you’re buying a brand, not genuine end-to-end capability. That lengthens implementation and it risks aspects of the supply chain breaking down when issues arise and internal expertise wanes.

You’re Always Covered

CTSI-Global operates squarely in each of those domains without resorting to other firms white-labeling under our brand. You’re covered with CTSI-Global; with other well-known providers, you may not be.

The Value of Being Carrier Agnostic

Insist on Transparency

CTSI-Global is carrier agnostic, with 20,000 carriers in our network, so there’s complete transparency and no conflict of interests.

Demand Full Access

Some logistics firms are contractually bound to a limited set of carriers, due to financial investment in those companies. That means you aren’t getting full access to the power of the open market.

Relax: You’re never going to look up and wonder if CTSI-Global can handle what you throw at us. That’s peace of mind and a long-term partner relationship, ready to go.

To learn more, contact us today for a free consultation.