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July 11, 2022

Four Reasons to Optimize Your Clinical Supply Chain Management

by
Slope

This is our third blog in a series of five on clinical supply chain management optimization. First, we explored who needs clinical supply chain optimization and then when you need to optimize your clinical supply chain management. This blog will discuss four reasons to optimize your clinical supply chain management, or in other words, the business benefits to be had.

Two years ago, a good portion of the U.S. population did not know what a supply chain was. Today, with store shelves empty and inflation rising, it's safe to say we do now. For clinical trials, supply chain issues that involve getting lab kit components, investigational product (IP), medical devices, ancillary clinical supplies, and biological samples to the right place at the right time are preventing clinical trials from staying on budget and completing within the planned timeline.

There are four high-level business benefits that result from clinical supply chain management optimization, each supported by a handful of positive operational outcomes that support these benefits. In summary, the four reasons to optimize your clinical supply chain management are to:

  1. Minimize Risk for your clinical trial
  2. Reduce the Costs of your clinical trial
  3. Improve the Productivity of clinical trial collaborators
  4. Increase Subject Retention so you make the most of each participant

Before we begin, we want to acknowledge the fact that optimizing your clinical supply chain management with clinical trial data management techniques that depend upon the use of spreadsheets, post-it notes, manual and paper-driven processes, or having research sites transcribe data from their systems into an EDC or other trial-specific systems just doesn't work. Digital transformation using a central, online system or platform that all the clinical trial collaborators use is required. We won’t go into the specifics of these systems or how they do what they do. Instead, we will focus on why you should take a hard look at implementing one for your clinical trials.

#1 Minimize Risk for Your Clinical Trial

There are a variety of risks associated with any clinical trial that clinical supply chain issues can make worse—data integrity, unexpected protocol deviations, changes a new amendment requires, timely identification of issues before they become major problems, or not having all the data needed to demonstrate either regulatory compliance or subject safety. These risks are amplified by the fact that today’s processes make it difficult for clinical trial sponsors and their clinical operations functions to coordinate and control their collaborators, such as clinical research organizations (CROs), research sites, laboratories, and distributors. The same issues apply to the couriers that transport clinical trial supplies from distributor to site and biological samples from site to lab to biorepository.

In the current day manual process, clinical trial sponsors hand over the clinical trial documents—the clinical trial protocol, lab manual, pharmacy manual, or other operational plans—and ship supplies to the research sites. As sponsors relinquish control of clinical supply, real-time visibility for the sponsor disappears, and in essence, clinical trial supply chain management defaults to collaborators. Clinical trial sponsors must trust that the research sites will enroll the subjects, conduct the procedures according to the clinical trial protocol and manuals, ship biological samples to the right lab at the right time in the right shipper, and maintain an inventory of the required lab kits and other clinical trial supplies. The sponsor only knows what actually went on after the fact, when it is entered into the EDC, or when the monitor comes on-site to verify billable activities.

Minimizing these risks is the first of four reasons to optimize your clinical supply chain management. Clinical supply chain management that is properly optimized minimizes risk by delivering:

  1. Operational Coordination and Control
  2. Protocol and Amendment Adherence
  3. Real-time Insights into Trial Execution
  4. Better Data Integrity
  5. Regulatory Compliance

Operational Coordination and Control

An online platform built to optimize clinical supply chain management provides a central place to define all supply-related clinical trial procedures and supply needs. The platform should be configurable to point back to the clinical trial protocol’s schedule of events and other associated manuals and guide collaborators through the protocol’s time points and required lab kits, investigational product (IP), devices, and ancillary or other supplies needed. The sponsor should also be able to define within the platform shipping instructions, standard shipping labels and manifests, which labs biological samples are to be shipped to, and when those labs are open to receive the samples. The same applies to standard requisition schemas for ordering lab kits and ancillary supplies, including which distributors to order each from. This gives the sponsor a level of operational control they have not had before.

Protocol and Amendment Adherence

With the standard processes defined in the online platform as described above, research sites can then access this source to guide them to conduct their activities according to the protocol. For example, to see what lab kits or other supplies they need for a procedure, where and when a biological sample is to be shipped, when a diary is expected to be dispensed, etc.  

Real-time Insights into Trial Execution

Since the procedures, clinical supplies needed, and shipping best practices are in the system, it makes sense that the same system can be used for inventory management. Research sites can log their inventory in the system, log when a lab kit is used to collect a biological sample, register the sample, print shipping labels and manifests, and log tracking information for the shipment. Having research sites log this activity in the system gives sponsors real-time insights into what is happening at the research sites on a given day or week from a dashboard–without waiting for the EDC update. They can also keep an eye out for issues so they can preemptively fix them. There is additional value in the real-time insights, but we will cover those in context in following sections.

Better Data Integrity

Now that research sites are logging the procedures they conduct, the lab kits they use, and how they ship biological samples as they perform the activities—instead of making handwritten notes somewhere and entering them into a system later—the data has a much better chance of being accurate. To take this one step further, making the lab kit and shipping materials scannable with a mobile device via smart, barcode-enabled labels removes the potential for data entry errors. And finally, audit trails generated from the online activity can provide additional documentation.

Regulatory Compliance

Regulatory compliance is the final category of capabilities that support our first of four reasons—minimizing the risk of your clinical trial—to optimize your clinical supply chain management. Because the activities at the research sites are being logged in a central system, it is far easier to encourage and track regulatory compliance. The logging itself supports compliance with FDA Good Clinical Practices (GCP) to maintain records in a single source of truth for activities at the research site. The system can also maintain an electronic record of IP and other clinical supply use, biological samples collected, and related activities during the trial with timestamps and attribution compliant with the FDA’s Attributable, Legible, Contemporaneous, Original, Accurate, and Complete (ALCOAC) regulations and guidances. In addition, research sites can log when they dispense a drug to the subject or use equipment and when they reclaim, return, store, or destroy unused items according to the Sunshine Act. And finally, when properly configured, the system can provide a means to create, modify, maintain, and transmit electronic records to ensure their authenticity, integrity, and, when appropriate, confidentiality in accordance with Title 21 CFR Part 11.

#2 Reduce Costs of Your Clinical Trial

Costs have long been a concern for the clinical trial industry—running clinical trials is expensive. While this is due to a plethora of reasons, there are a few reasons that are specific to clinical supply chain management, which brings us to the second of our four reasons to optimize your clinical supply chain management, reducing costs. The clinical trial industry is experiencing the same demand-exceeding-supply issue consumer goods are facing today. In the past, lab kits and ancillary supplies could be ordered in large quantities without much concern about their availability, cost, or creating waste by ordering too many, but those days are at an end. Adding to supply chain costs is the fact that the operational and logistical management of clinical supply chains is very manpower intensive, relying on the manual coordination of supplies, inventories, and orders. Our current processes make it difficult to plan in a way that increases efficiency and reduces costs.

Optimizing your clinical supply chain management supports your initiative to reduce costs by facilitating:

Improved Resource Planning of Supplies, Schedules, Procedures, and Personnel

One of the great capabilities of using an online platform for clinical supply chain management is the opportunity to establish a central calendar of the subject visits and related procedures scheduled at each research site. When the research sites enroll a new subject in the clinical trial, they can add that subject and the schedule of their procedures to the calendar. This allows the research site and sponsor to forecast the quantity of lab kits, IP, devices, and ancillary supplies they will need and when. As a result, they can check current clinical supply inventories, expiration dates, and equipment calibration dates and place orders accordingly. This also informs them of the personnel they will need on-site to conduct the procedures—particularly valuable when special skills are required. The same data can be used to give couriers, laboratories, and biorepositories an automatic heads up about biological samples coming their way so they can plan accordingly. With proper resource planning, unnecessary expenses that result from last-minute fire drills can be eliminated.

Cost-effective Supply Orders

As we mentioned in the first section above, Minimize Risk for Your Clinical Trial, this online system to optimize your clinical supply chain management has supply distributors, standard requisition schemas, and procurement processes defined for lab kits, IP, devices, and ancillary and other supplies. In the better data integrity section above, we introduced the concept of smart, barcode-enabled labels. These “smart labels” can track each item, where it is stored down to a shelf in a closet, its lot number, expiration or calibration date, and when something is used—for example, to collect a biological sample. This gives research sites and sponsors insight into how many of each item is available for use at each location. When coupled with the calendar of subject procedures scheduled at each location, those responsible for reordering supplies can see the quantity needed across sites. This allows for forecasting supply needs over a period of time and placing cost-saving quantity orders of items that will actually be used—not too much, and not too little. No more last-minute rush orders from the most expensive distributors because they are the only ones able to deliver on time.

Increased Valid Samples

The ability to forecast the exact number of supplies needed at each site over a period of time makes it possible to ensure that each research site has the correct lab kit, IP, device, and ancillary supplies needed for every procedure. This prevents research sites from running out of something the protocol calls for and having to improvise with other components—for example lab kit components—that result in a protocol deviation or invalidate a biological sample from being used in the clinical trial. It is expensive to have a subject return for a do-over procedure and even more expensive to have to replace a subject eliminated because there is no valid biological sample for a time point or because they dropped out due to a bad experience.

Reduced Supply Waste

Optimizing your clinical supply chain management will also reduce wasting lab kits and ancillary supplies due to ordering too many. A recent analysis of over a million Slope data points suggests that 87% of lab kits ordered for clinical trials never get used. When too many are ordered, they have to be reclaimed, donated, returned, or worse, destroyed because they expired—a big waste of valuable supplies and budget.

#3 Improve the Productivity of Clinical Trial Collaborators

One major challenge with clinical trials is the diverse set of processes and procedures different collaborators such as sponsors, CROs, research sites, labs, distributors, and couriers use—many of which are paper and spreadsheet-based. If these processes are supported by systems, they tend to be single-purpose, such as portals for procurement, distributor portals, systems for labs, or internal research-site systems. With everyone working their own way in different systems there is limited opportunity to optimize efficiency and productivity for the clinical trial as a whole. This makes it difficult to reconcile data from different collaborators, which adds time and effort to clinical trial data management. Communications tend to be inefficient too. Ad hoc emails, texts, phone calls, and in-person visits compose the majority of communications, which makes it hard to know who has been informed of an incoming shipment, that an order has been placed, or that more lab kits are needed.

The third of four reasons to optimize your clinical supply chain management is improving the productivity of all the collaborators by getting them working consistently, correctly, and efficiently with best-practice workflows and processes that you define, control, and track. An online platform focused on clinical supply chain management optimizes productivity for all collaborators with:

Standard Processes

As we mentioned in reason #1 Minimize Risk for Your Clinical Trial, clinical trial sponsors can set up their standard best-practice processes in the clinical supply chain optimization platform for:

  • Procurement management, including standard requisition schemas and preferred distributors
  • Shipping management with shipping instructions, guardrails, and label and manifest generation
  • Procedures according to the protocol and their timing for each subject
  • Clinical supply inventory management at research sites

These best-practice processes not only improve productivity, they also support protocol adherence since they are configured into the system specifically for each clinical trial’s protocol based on the lab, pharmacy, and operations manuals, and any amendments.

Streamlined Workflows

The same standard processes defined above can be streamlined to everyone’s benefit. Each collaborator does not have to set up their own processes or decide how to execute the trial. The clinical supply chain management platform guides them instead. Since all activities are logged in the system, it is less likely people will perform redundant tasks. They will be able to see in the system that the task was already done. When someone is not sure what to do, they do not have to check their personal notes or pull out the protocol manual, they simply check the online system that everyone is using. This gives your clinical trial efficient, streamlined workflows for procurement management, shipping management, maintaining subject visit calendars, clinical supply inventory management, and biological sample management.

And since the system is online, it can be accessed anywhere, anytime, from any web browser, on any device—including mobile devices—so it is right at their fingertips and they don’t have to go back to a desk with a computer or terminal to log on to the system. With the barcode-enabled lab kit labels, data entry is no longer required for logging lab kit arrivals, where they are stored, when they are used, or when they expire.

And since we have eliminated the need for many of the manual processes that create data silos, clinical data management and integration become far more efficient, not to mention more accurate.

Streamlined Communications

Communications between collaborators are also streamlined because everything is being done within or driven by the online platform. Notification emails and alerts can be automatically generated so people know when to order things or that something needs to be done. Persona-based, real-time dashboards and reports eliminate the need for many ad hoc communications. Automatically-generated audit trails document all activities for future reference.

A couple of extremely valuable communications are possible within the platform and worth calling out here.  For example:

  • Labs can automatically be sent an electronic notification that a biological sample shipment is on the way and its manifest.
  • Labs can note that they received the biological sample shipment and its condition.
  • Any type of shipment can be tracked within the system in real-time by pulling data from courier tracking systems so that no one has to ask, “where is my shipment?. Everyone can just check the system.
  • Shipment delays can automatically generate notifications so issues can be handled proactively without a lot of back-and-forth emails and phone calls.
  • When clinical supply inventories go below a threshold or are within expiration windows at any research site, the system can notify the right people that replenishment is needed or automatically place the order.
  • Subject visit calendars are in the system so no one has to ask, “what do you have going on at your research site this week?” or “how are subjects progressing through the trial?”

It is important to note that these communications not only streamline communications but also improve their accuracy. One example is that queries are typically reduced.

Collaborator Coordination

I think you can see how these standard, streamlined processes and communications through a clinical supply chain management platform aid in coordinating collaborators and keep everyone working together as a well-oiled machine. A good example of the value of this is when different sites are on different protocol amendments. This can be very confusing to manage, not only for the sponsor but also for the research sites themselves. When a new amendment is taken live at a research site, the platform is reconfigured to incorporate the changes the amendment requires for just that site. So the procedures, processes, and guided workflows the personnel at that site are accessing have the amendment baked in. This makes it very easy to harmonize activities across amendments and sites.

#4 Increase Subject Retention

Many things can cause subject loss, their experience when sites are not ready for them, being turned away because the supplies or personnel required for a procedure are not available, lost biological samples that were critical to keeping the subject in the trial, or spoiled samples because they were shipped incorrectly or arrived at the laboratory when no one was available to receive them.

Our fourth and final of four reasons to optimize your clinical supply chain management is subject retention. An optimized clinical supply chain management approach to managing your clinical trial helps retain clinical trial subjects in four ways;

Sites Have What They Need When They Need It

Optimizing your clinical supply chain management with an online platform as we described above makes sure the research sites have the correct, usable lab kits, IP, devices, and ancillary clinical supplies they need for every subject procedure. The system knows each site’s inventory, any expiration or calibration dates, and where the inventory is stored. Before inventory runs too low, the system can automatically place an order or send an alert to the procurement team to place a resupply order, the quantity needed, and when the supplies are needed to support the visits in the subject procedure calendar.

Sites Are Prepared for Every Visit

With the subject procedure calendar keeping research site coordinators informed of what is on their schedule today, this week, or month, and the automatic inventory management making sure the necessary lab kits, IP, devices, and ancillary clinical supplies are available, sites are always prepared for every visit. They never have to turn a subject away, miss a necessary safety procedure, or give the subject a negative experience.

Spoiled Biological Samples Are Reduced

Due to the shipping management workflows and guardrails detailed in Operational Coordination and Control, biological samples are packed properly, in the proper shipper, and kept at the temperature needed to prevent them from spoiling in transit. Biological samples are shipped at the correct time so that they arrive at the lab when their receiving team is available. The lab staff has advanced notice that biological samples are coming. The lab technicians required to analyze the biological samples know to be available to process them in a timely manner. Subjects will no longer be eliminated or have missing safety results due to their biological samples becoming unusable. The same applies to shipments to biorepositories.

Lost Biological Samples Are Reduced

The same shipping management workflows and guardrails prevent a sample from getting lost. With biological sample labels, shipping labels, and manifests being generated by the system, the potential for a sample getting lost due to human error or unreadable handwriting is gone. The combination of data-enabled barcodes on lab kits and pulling data from courier tracking systems allow anyone involved to track biological samples as they travel from location to location. A subject should never get eliminated due to one of their biological samples ending up in the wrong location or lost all together.

The Slope eClinical Supply Chain Management Platform Addresses the Four Reasons to Optimize Your Clinical Supply Chain Management

The Slope eClinical Supply Chain Management platform provides a collaborative workspace to define protocol-specific workflows and processes to guide supply procurement, inventory management, and biological sample collection, shipping, routing, and tracking. Slope uses these guided workflows alongside real-time demand data at the research site and patient level to orchestrate the operational execution of complex study protocols. All actions are logged in a central source of truth to provide complete audit trials.

The Slope platform optimizes your clinical supply chain management by:

‍Stay tuned

This is the third of a series of five blogs on the topic of clinical supply chain management optimization.

Published

  1. Who Needs Clinical Supply Chain Optimization discusses sponsor, site, and clinical research study attributes that suggest optimizing your clinical supply chain management will be beneficial.
  2. When You Need To Optimize Your Clinical Supply Chain Management lists a series of signs that indicate you need to optimize your clinical supply chain management.
  3. Four Reasons to Optimize Your Clinical Supply Chain Management covers the business benefits of optimizing your clinical supply chain management.

Coming Soon

  1. Requirements for an eClinical Supply Chain Management Platform will describe the necessary features and capabilities of a platform to optimize your clinical supply chain management.
  2. How to Implement an eClinical Supply Chain Management Platform will outline the process to implement a platform that optimizes your clinical supply chain management.

Learn more by booking an appointment with a Slope Solutions Expert.

Read More

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