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April 14, 2022

When You Need to Optimize Your Clinical Supply Chain Management

by
Slope

The execution of clinical trials involves many dynamic, moving parts. For example, there is the protocol design, protocol amendments, patient visit schedules, investigational product (IP), lab kits and clinical supplies for the procedures, biological samples, shippers to get the samples to labs—to name a few. In addition, there are a variety of stakeholders that keep these dynamic parts moving—clinical operations teams, IP suppliers, clinical supply vendors, couriers, labs, and auditors. And finally, there are multiple clinical research sites that may or may not be part of the same organization. To complicate things, each stakeholder has staff with varied working hours and responsibilities beyond any single trial. All of this takes significant coordination, so it is no wonder mistakes happen and issues arise. However, there are a number of mistakes and issues that signal that it is time to optimize your clinical supply chain management. 

In this blog, the second in our series on clinical supply chain management optimization, we’ll highlight these mistakes and issues and the operational problems they cause that can negatively impact the probability of a successful clinical trial.

We will organize our discussion of when you need to optimize your clinical supply chain management around four key areas:  

  • Collaboration
  • Visibility
  • Biological sample traceability and chain of custody
  • Compliance and protocol adherence

Collaboration Issues Signal It’s Time to Optimize Your Clinical Supply Chain Management

During the course of a clinical trial, stakeholders need to communicate with each other to perform and coordinate activities. Research sites need to reorder lab kits and other clinical supplies. Sponsors need to get the IP to the research sites. Couriers need to be scheduled. Labs need to be alerted that biological samples are on the way for analysis. But rarely is there a well-defined, standard process for these interactions. 

As a result, when someone has a need—let alone an emergency—they are not sure whom they should contact, the communication method that will be most effective, when they can expect a response, or how to track the inquiry and response. Or maybe standard processes exist, but they are different for each stakeholder or task—some stakeholders expect an email, some prefer phone calls, others have a portal to submit requests. To complicate matters, stakeholders have their own method for tracking these requests, including everything from sticky notes and paper forms to spreadsheets and software systems.  

This lack of standard collaboration processes across stakeholders puts a huge burden on each individual to track and monitor themselves. In the chaotic and constantly changing world of clinical trials, mistakes will happen—and are often noticed only after it's too late to fix them. Here are some signs that it is time for you to optimize your clinical supply chain management to improve collaboration.  

Research Sites Have Too Many Lab Kits or Not Enough

Lab kits are often procured by the sponsor for economies of scale and shipped to the research sites in bulk ahead of the trial. This is typically done without regard to the number of subjects enrolled in the study at each site, the different procedures required at different timepoints, or the potential for protocol amendments to change these procedures. The catch is that lab kits have components that expire and, if not used, must be discarded.  

You need to optimize your clinical supply chain management when:

  • Research site supply closets are overflowing with unused lab kits, clinical supplies, and shippers
  • Sponsors buy in bulk, only to have many of the kits expire, be discarded, or donated
  • Research sites have to scramble to gather lab kit components to meet the needs of immediate subject procedures 
  • Biological samples become invalid because research sites had to improvise components to conduct scheduled procedures

Ordering lab kits and clinical supplies in advance leads to waste, unnecessary expense, and invalid biological samples. It also puts an undue burden on research sites to organize, store, track expiration dates, and dispose of unused lab kits—and a site coordinator’s day is already chaotic and stressful. So the potential increases for mistakes that result in protocol deviations, delays, and samples that fail to provide the desired data.

No Consistent Process To Order And Resupply Clinical Supplies Across Sites

Research sites involved in the same clinical trial can have different processes for ordering, tracking, and storing their inventory of IP, lab kits, and clinical supplies. Some may have no formal process at all, leaving it to individuals to notice when supplies are low and remember to place reorders. Without a formal process to place the orders and notify other site staff that supplies are coming, people can forget if they placed that supply order. Redundant orders could be placed, or supplies might not arrive in time for scheduled subject procedures resulting in turning away the patient.

You need to optimize your clinical supply chain management when:

  • Site coordinators can’t remember if they placed a needed resupply order
  • Research sites don’t know if anyone ordered the needed supplies
  • Research sites don’t know when needed supplies will arrive
  • Research sites place redundant orders
  • Research sites place incomplete orders

Research site personnel only know the procedures that have been established. Inventory management is only a small part of their training or experience. It is unrealistic to expect them to be expert inventory managers. 

As a result, research sites don’t always make consistent, complete, and cost-effective supply orders. The costs of this can be hard to see, but in the end, it is the sponsor that ends up paying the price in unused kits, subject attrition stemming from delayed procedures, invalid biological samples, overall clinical trial delays, and potentially an unsuccessful trial. 

No Real-time Visibility? Time to Optimize Your Clinical Supply Chain Management

Most of the time, stakeholders in a clinical trial have little or no idea how much IP, lab kit, or clinical supply inventory they have, where it is, and how it got there. The same issue can arise with valuable biological samples. The current inventory, locations, and movements of lab kits, biological samples, IP, and other supplies are often discovered through phone calls, emails, reconciling multiple spreadsheets, or other research–by which time the data may no longer be up to date.

When a clinical trial stakeholder needs this kind of information and can’t find it—or only can find it with a lot of wasted effort and a long delay—it negatively affects operations. In the end, these visibility barriers undermine the effectiveness of the clinical trial.

Here are some visibility issues that indicate it is time to optimize your clinical supply chain management.

Clinical Supply Inventory Tracking Is Delayed or Neglected

While research sites may have the occasional slower period, most days are extremely busy. When there is a rush, lab kits and supplies are often used without being recorded, with the intention of recording later when things are calmer. But things don’t always get calmer. 

You need to optimize your clinical supply chain management when:

  • Estimates stand in for accurate inventory numbers
  • Every rush period is followed by inaccurate inventory numbers
  • Research site staff have to abandon tracking to deal with patient needs and, despite their best intentions, forget to update inventory numbers
  • Research sites don’t have the correct lab kits they need to conduct procedures
  • Research sites don’t have the shippers they need to ship biological samples in accordance with the protocol
  • Research staff absences lead to inaccurate data, requiring extra effort to investigate and resolve

Time-consuming manual inventory tracking can’t keep up with the fast daily pace at research sites, let alone during rush times. Recorded inventories fall out of sync with what is actually on hand, leading to a lack of appropriate lab kits for patient visits, or the over-ordering of supplies that were already ordered.

Too Much Clinical Research Data, But Not The Data Needed

Each stakeholder needs to see and interact with a specific subset of all available operational data to focus on the aspects of the clinical trial of significance to them. The data enables them to perform their duties properly and make decisions appropriate to their role and goals. 

But there is rarely an up-to-the-minute single source of truth that represents:

  • The lab kit, IP, and clinical supply inventory across research sites and suppliers 
  • The subject procedures happening across research sites on a given day or week
  • Biospecimen location and status

Instead, the data resides in different spreadsheets, databases, and personal notes, each creating its own data silo. To get a comprehensive view, the data in these silos needs to be migrated, transformed, and integrated—a time-intensive and costly process—that renders the data out of date by the time it can be analyzed.

You need to optimize your clinical supply chain management when:

  • Stakeholders such as research sites and ClinOps teams are using their own spreadsheets and systems to track important data
  • Stakeholders aren’t aware of available data that could significantly improve their operations or the trial as a whole
  • Not all stakeholders generate regular reports that summarize the most essential data
  • Stakeholders create reports that are incomplete, inconsistent, and do not reflect best practices
  • Reports are challenging to generate, so ClinOps teams do not make the effort—and consequently miss out on valuable insights
  • Important events are missed, leading to stockouts, missed visits, and other problems due to a lack of the needed data
  • Reports don’t focus on the most important concerns of the receiving stakeholder
  • There is a multi-day delay in aggregating data from the various research sites and labs for analysis by the sponsor and ClinOps team

As the complexity of clinical trials increases, so does the amount of data. One study found that today’s clinical trials require 70% more procedures, 85% more endpoints, 88% more data points collected, and 60% more research sites. These increases will result in more data silos and longer lead times to aggregate the data needed unless the industry starts to optimize clinical supply chain management.

If You Lack  Biological Sample Traceable Chain of Custody—Optimize Your Clinical Supply Chain

When a sponsor wants to know the whereabouts and status of biological samples, they don’t want to wait a week to find out. It is not always easy to determine when a biospecimen was collected, where, and by whom. Let alone who else was in possession of them along the way. This has a serious adverse effect on data integrity, which impacts the results of the clinical study. 

There are many moments when errors creep into even well-managed procedures and sample handoffs—especially if they are carried out manually. In the moment of handling a biospecimen, it’s easy to forget that someone else down the line might need information about who you are, what you did, and when you did it to do their jobs effectively,

Below are some traceable chain of custody issues that act as signs that it's time to optimize your clinical supply chain management.   

Incomplete Data About Biospecimens

Handwriting is still commonly used to identify biological specimens, create shipping manifests, create shipping labels, and acknowledge shipment receipts. Writing information and ensuring that it is attached to the correct vial, inserted into the right shipper, or attached to the right shipment is a high-effort and time-consuming process. Because they are handwritten, these labels and documents are often hard to read or contain incomplete information.

You need to optimize your clinical supply chain management when:

  • Handwriting slows processing and delays the delivery of biological samples
  • Analytical laboratories can’t identify the subjects associated with specimens from their labels
  • Labels and manifests lack crucial information necessary for tracking
  • A biospecimen has no record of which courier transported it, when it was shipped, who shipped it, when it was received, and by who

Handwriting labels and documents are inadequate for a reliable clinical supply chain. It is time-consuming and tedious for research site staff and takes them away from other tasks. Lab technicians lose time deciphering handwriting or communicating with the sender to track down the data they need. Numerous hard-to-trace errors result from handwriting, with potentially serious consequences to the amount and quality of data produced by a clinical trial. Sponsors face the possibility of failing to show the results necessary for a successful clinical trial.

Analytical Laboratories Receive Inadequate Information About Incoming Biological Sample Shipments

The handoff of biological samples from research site to analytical laboratory is crucial. Yet, it is prone to error, lack of notification, and a lack of clarity on who has responsibility for the sample at any given time.

You need to optimize your clinical supply chain management when laboratories:

  • Find shipments arriving without complete manifests
  • Receive shipments without prior notification
  • Don’t have a consistent way to confirm receipt with other clinical trial stakeholders
  • Claim they never received a biospecimen that was supposedly shipped to them
  • Find shipments on their loading dock that were delivered when no one was there
  • Deem samples unsuitable for processing because their shipping schedule was never communicated to the lab, and they've been sitting on the loading dock for too long

Even biological samples that are properly obtained, correctly packaged, and promptly shipped can be lost or delayed without being noticed for days. With the large number of samples in transit in today’s clinical trials, delays in realizing that something has been lost, delayed, or shipped improperly can negatively impact the quantity and quality of clinical data generated by the trial. And when data integrity is in question, the clinical trial is at risk.

Compliance Problems Indicate It’s Time to Optimize Your Clinical Supply Chain Management

During a clinical trial, there are many times when poorly defined workflows, uncontrolled data access privileges, lack of audit trails, lost data, and non-standard data recording processes can lead to compliance issues that an audit will reveal. These problems multiply as the number of studies at an individual research site increases.

The challenge of compliance is amplified by the fact that today’s protocols are dynamic. 60% of protocols require one or more amendments. The average protocol has 2.3 amendments, and each amendment requires an average of 6.9 changes to the protocol.

Below are some instances when you could benefit from optimizing your clinical supply chain management.

Multiple Live Amendments Running Concurrently  

When study protocols are amended, they may change procedures, requirements, and/or visit schedules. As a result, some types of procedures might have changed, while others remain the same. In the hectic world of research sites, not all staff get informed of newly implemented amendments and the changes they require at the same time. It’s not surprising that mistakes happen, and these mistakes can lead to a protocol deviation, or a sample that is rejected and therefore wasted. Subjects can even be eliminated from participation if one of their biological samples was incorrectly collected. 

You need to optimize your clinical supply chain management when:

  • Biological samples are classified as invalid because they were not collected according to the appropriate protocol and active amendments
  • Subjects are being eliminated from study participation because one or more of their procedures were conducted incorrectly 
  • Different protocol amendments are in operation at different sites
  • There is confusion at research sites about which amendment is in effect

The complex procedural landscape created by protocol amendments can cause confusion and lead to biological samples that can’t be submitted for laboratory analysis. When staff aren’t sure their workflows are consistent with the current amendment, they need to double check, which slows their work, and creates anxiety about involuntarily causing a protocol deviation. Today’s complex protocols and their many amendments create the potential for multiple errors that result in a delayed or unsuccessful clinical trial.

Poorly Defined Role-based Access Privileges to Clinical Trial Data

Efficient clinical trial operations depend on the right people having access to the right data at the right time, while preventing unauthorized access that can lead to data loss, shipment errors, confidential data exposure, and data integrity issues. Individually maintained spreadsheets, paper forms, and email and phone messages are often shared without tracking who had access when. A wide range of potentially serious compliance issues can result.

You need to optimize your clinical supply chain management when:

  • Important data has been changed, but no one knows when or by who
  • Data that reaches the sponsor and clinical operations teams is inconsistent or suspicious
  • Principal investigators and auditors raise questions about data integrity
  • Required data is missing
  • There is no audit trail associated with the data

Authority and responsibility for clinical trial data access must be properly delegated and controlled. Any actions taken with the data must be logged and tracked. Without this, the chance of unauthorized access, inadvertent errors, and protocol deviations will always exist. Unauthorized access can lead to an audit, with attendant delays, and will affect the schedule and outcome of the clinical trial.

How to Optimize Your Clinical Supply Chain Management

If you are thinking that it may be time to optimize your clinical supply chain management, there is a software-enabled solution that helps each stakeholder in a clinical trial effectively document and communicate what they need, what they did, when they did it, and how they did it.

An eClinical Supply Chain Management (eCSCM) platform coordinates and automates clinical trial supply chain activities for:

  1. Vendors that direct supply shipments to research sites
  2. Research sites that store supplies, use IP, collect biological samples, and create laboratory-directed shipments 
  3. Laboratories that receive these biological samples
  4. Sponsor and clinical operations teams who need compliance, traceability, real-time visibility, and collaboration across all stakeholders

Slope provides an online eClinical Supply Chain Management platform for sponsors of complex, sample-intensive, early-phase clinical trials. Slope excels at oncology, rare disease, and gene therapy clinical trials. 

The Slope platform optimizes your clinical supply chain management. It:

  • Fosters collaboration between sponsors, sites, vendors, labs, biorepositories, and couriers
  • Provides real-time visibility into activities at research sites
  • Ensures traceable chain-of-custody for supplies and samples in use, transit, and storage
  • Assures compliance and protocol adherence consistently across research sites and laboratories

If you believe you are someone who needs to optimize your clinical supply chain management,

Learn more by:

Stay tuned

This is the second of a series of five blogs on the topic of clinical supply chain management optimization. The first was Who Needs Clinical Supply Chain Management Optimization.

Future blogs will discuss: 

  • Why You Need Clinical Supply Chain Management Optimization
  • What is Clinical Supply Chain Management Optimization
  • How to Optimize Your Clinical Supply Chain Management 

Latest news

Read more
August 26, 2022
Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform
Biological samples from subjects are the most valuable assets that travel across the clinical trial’s supply chain. Any gap in the knowledge in the biological sample's lifecycle can make the subject non-evaluable and jeopardize overall data integrity. If this happens too often, the overall clinical trial can be at risk. When shipping biological samples, clinical research sponsors must have the data they need to conduct biological sample reconciliation—meaning they have documentation to track a biological sample stored in a biorepository back to the lab that analyzed it, the courier that transported it, the research site that collected it, the lab kit that was used and its lot and serial number, and the lab kit’s distributor and manufacturer. This data allows the sponsor to prove that a biological sample is valid and has not been tainted anywhere along the way. As a result, an online platform must maintain an immutable record of all of the steps a biological sample takes throughout its journey from collection through storage, along with the steps taken by each collaborator, including sponsors, contract research organizations (CROs), research sites, distributors, labs, and couriers. As a result, an eCSCM platform must be able to prove a traceable chain of custody for biological samples, lab kits, investigational product (IP), devices, and ancillary and other clinical supplies, whether in use, transit, or storage.