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April 1, 2022

Who Needs Clinical Supply Chain Management Optimization

by
Slope

While sponsors rely on efficient study design, planning, and execution to get their products to market, logistical challenges almost always make it difficult to ensure that sites are prepared for their patients. Keeping track of investigational product (IP), lab kits, equipment, and other supplies is a clinical operations problem that often results in missing study drugs, expired lab kits, lost biological samples, and delayed resupply shipments—all signs that there is a need for clinical supply chain management optimization.

This systemic issue impacts studies across all therapeutic areas and phases—over 80% of clinical trials are delayed more than a month. Clinical trial supply chain inefficiency is a significant underlying cause of these delays. A poorly managed clinical supply chain leads to cost overruns, compliance problems, increased patient burden, lost and unusable biological samples, and data integrity issues.

While many clinical trial software and data management solutions have been developed, they’ve all sidestepped a fundamental operational challenge that impacts every clinical trial stakeholder. This problem persists across site-based, decentralized, and virtual study designs, and is connected to all investigational product (IP), lab kits, equipment, and biological samples:

  1. No one knows what clinical supplies they have
  2. No one knows what clinical supplies they need
  3. No one knows how their clinical supplies got to where they are

At a high level, you are someone who needs clinical supply chain management optimization if you have trouble with:

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

You Need Clinical Supply Chain Management Optimization If You Have Trouble With Compliance And Protocol Adherence

Modern study designs are increasingly complex, requiring up to 70% more biological samples to generate the results desired by the sponsor and mandated by the protocol. This inevitably leads to more lab kits, more procedures, more clinical supply chain activity, and more opportunities for things to go wrong. 

Protocol adherence is already a challenge for research sites managing more than a handful of studies. Tracking and documenting the interdependent activities that generate data for today’s complex study designs requires strict procedural compliance. The increasing logistical load—combined with stringent regulatory requirements—ultimately challenges the standard clinical operations playbook that research sites, sponsors, and CROs have relied on for decades.

Below are some signs you could benefit from clinical supply chain management optimization.

Sponsors That Can’t Guarantee Consistent Processes

For a successful trial, all biological samples must be collected at the appropriate timepoint, registered in accordance with the procedures outlined in the lab manual, stored properly, shipped promptly, and reconciled, but this is often not the case. 

You are someone who needs clinical supply chain management optimization if:

  • Research sites are taking biological specimens using lab kits assembled from the wrong or unapproved components
  • The wrong biological samples are being taken from patients according to the timepoint they are at in the study
  • Lab biological specimen collection procedures vary from site to site or from individual to individual taking the sample
  • Biological specimens are processed differently by different analytical laboratories
  • Different laboratories use slightly different processes when transferring biological specimens to the biorepository

Inconsistent processes lead to inconsistent results. This can make it difficult to normalize, reconcile, and harmonize data from different sources, reducing the validity and usability of the data generated by the clinical trial. This can even prevent the clinical trial from demonstrating that it reached its endpoints.

Research Sites That Have Undefined Workflows

Study documents govern operations, but they often don’t translate into crystal clear procedures for the clinician. Protocol amendments make this task even more complex and uncertain. 

You are someone who needs clinical supply chain management optimization if your:

  • Sites have collected a biological sample incorrectly
  • Sites have had to use the wrong lab kit for a sample collection
  • Biological samples have been stored at the wrong temperature
  • Biological samples are sometimes shipped improperly, causing biological sample loss
  • Biological samples are sometimes mistakenly sent to the wrong lab
  • Sites struggle to collect biological specimens in accordance with the most recent IRB-approved amendment

Without defined workflows, research sites can’t improve their operations. Errors and inaccuracies are inevitable, resulting in inefficiencies and protocol deviations. 

You Need Clinical Supply Chain Management Optimization If You Are Having Trouble With Biological Specimen Traceability And Chain Of Custody

Biological samples are the most valuable assets that travel across a clinical trial's supply chain. But an overreliance on manual coordination means that clinical operations teams are operationally disconnected from the stakeholders, assets, and activities associated with sample collection, routing, analysis, and reconciliation.

Manual coordination cannot effectively guarantee sample chain of custody, which refers to all the steps in a clinical supply chain where different stakeholders take possession of IP, lab kits, and biological samples. A credible chain of custody system provides a detailed record of the sequences of possession, along with supporting documentation for all associated activities and events. Any loss of visibility creates gaps in a sample's lifecycle, which means it can no longer be relied on to accurately inform study results.

Here are some signs you could benefit from clinical supply chain management optimization.

Sponsors That Have To Rely On Untrackable Lab Kits

Lab kits—while a strategically important part of almost every clinical trial—haven’t evolved to keep pace with the changing demands of modern clinical research. As the number of biological sample collection procedures increases, the capabilities of your lab kits should too. Modern, smart lab kits leverage digital twin technology to track all the components (tubes, swabs, etc.), collect important metadata (serial numbers, lot numbers, expiration dates), and associate the kit with activities such as sample collection, shipment, and reconciliation. 

You are someone who needs clinical supply chain management optimization if: 

  • You can’t automatically track the chain of custody for each individual biological sample starting from vendor to lab kit, patient, research site, to lab.
  • You are losing too many biological samples due to workflow or shipment issues
  • Hand-labeling of individual vials is difficult to read and results in longer processing times, delaying biological sample shipments
  • Cryo-vials lose their tracking data because of poor label adherence
  • Biological samples are linked to the wrong patient or wrong visit, reducing data quality

Incomplete chain of custody reduces the quality of the data generated by the clinical trial, potentially leading to failure to demonstrate reaching clinical endpoints.

Sponsors That Don’t Know Where Their Biological Samples Are

A successful clinical trial outcome depends on having enough valid biological sample data to understand efficacy and produce meaningful results.

You are someone who needs clinical supply chain management optimization if you face:

  • Lost or misrouted biological samples
  • Incorrectly handled biological samples
  • Improperly stored biospecimens
  • Inadequately shipped biological samples
  • Mislabeled or misidentified biological samples

Clinical trial patients have put in the effort to travel to the site, be dosed, and provide biological specimens—only for many of these biological specimens to be damaged or lost, and so never contribute valid data. This leads to a reduction in the amount and quality of clinical data that can be submitted, and may lead to a failure to demonstrate achieving clinical endpoints.

Sponsors That Can’t Track Problems Back To Their Causes

Often, the cause of a current problem lies with past decisions or data inadequacies, and solving it requires accurately identifying its root causes. 

You are someone who needs clinical supply chain management optimization if you don’t have audit trails of:

  • Every action taken from the problem’s inception
  • The path of every single biological specimen, from start to biorepository
  • The course of every shipment, with every detail of pick up, conditions en route, and delivery place and time
  • Every time data was updated or changed, who changed it, and their authorization
  • Every acceptance of a shipment by research site or analytical laboratory, including who accepted it

Without audit trail capability, establishing the causes of problems is impossible. As a result, the same problems will continue to plague future clinical trials, increasing the work required and leading to staff burnout.

You Need Clinical Supply Chain Management Optimization If You Are Having Trouble With Visibility

During operations, clinical trial stakeholders store, ship, and receive IP, lab kits, supplies, and biological samples. Sponsors, research sites, labs, and other stakeholders have poor information on what is where, and little control to make sure that the right things are happening at the right time. For clinical trial success, every stakeholder needs real-time visibility into the location and status of everything involved in the trial. Here are some signs you could benefit from clinical supply chain management optimization.

Research Sites That Have Trouble Managing Clinical Trial Supplies

To do their jobs, clinical research sites store large amounts of the necessary IP, lab kits, equipment, and other supplies. 

You are someone who needs clinical supply chain management optimization if:

  • Your site facilities are not designed to make storage or retrieval easy
  • Your lab kit and ancillary supply storage is disorganized 
  • Your research sites have had to turn research subjects away because lab kits were expired or missing
  • Your research sites have an oversupply of lab kits and supplies due to unnecessary reordering 
  • You have had to throw away unused lab kits and supplies
  • It is very time-consuming to do manual inventory when things get out of hand

Research site staff spend time struggling with inventory issues rather than clinical work. For research site staff who are already overworked, this can make their days even more hectic and stressful than they already are.

Sponsors That Are Frustrated By Messy Data

Clinical trial records are kept in multiple spreadsheets, databases, and paper records, in a variety of formats, updated in different ways. Combining or reconciling them takes time, effort and expertise that is not often available. 

You are someone who needs clinical supply chain management optimization if:

  • You find the same procedure, patient, or biological specimen identified in different ways in different records
  • You have trouble identifying and reconciling duplicate records
  • Comparing databases requires conversions, crosswalks, and other complex procedures
  • It is often unclear who last updated a record, or what their authority was
  • Records are often missing significant information

Without a single system of record, it is impossible to maintain a single version of the truth that reflects all clinical supply chain activity. This results in numerous duplicate records, missing records, and records with inadequate data. This can cause difficulties in case of an audit, reduces the amount of available high-quality data, and can result in the clinical study not reaching its clinical endpoints.

Sponsors That Can’t See Activities Across Research Sites

Site activity reporting is inconsistent, and often incomplete or delayed. This hinders sponsors from identifying and dealing with problems before they become significant.

You are someone who needs clinical supply chain management optimization if:

Some sites are showing delays in seeing patients

  • Some sites are running out of the Investigational Product (IP) while others are oversupplied and are returning expired amounts
  • Some sites show an unusual amount of lab kit wastage
  • A site creates a lower percentage of valid biological specimens than most others
  • A site shows a high rate of shipping delays

It’s impossible to improve processes that you can’t see or measure. Sponsors are reduced to putting out fires that should have been identified long before. Sites enroll and study fewer subjects than they otherwise would, endangering the success of the clinical trial.

You Need Clinical Supply Chain Management Optimization If You Are Having Trouble With Collaboration

Clinical trials involve many organizations, individuals, and services, all with their own workflows and goals. For a successful clinical trial, all these stakeholders—sponsors, sites, CROs, laboratories, vendors—need to collaborate and coordinate their efforts. Below are some signs you could benefit from clinical supply chain management optimization.

Clinical Trial Sponsors That Have Trouble Managing And Aligning Stakeholders

You are someone who needs clinical supply chain management optimization if you are having trouble maintaining consistent communication and coordination between all of your stakeholders.

Some signs that you are experience these problems are:

  • Research sites say they sent biological samples properly, but the receiving clinical laboratory insists they did not receive them
  • Lab kit vendors say they need more lead time, while research sites say they ordered far in advance of need
  • Your translational medicine team say they are getting poor quality results from the analytical lab, which blames the research site, which in turn blames poor communication around protocol amendments
  • Biological specimens reach the biorepository through an opaque process entirely run by the analytical laboratory
  • Reallocating supplies between research sites requires multiple phone calls and digging into databases

Problems can become significant before being identified, and even then responsibility for solving them is hard to establish. This can result in unnecessary conflict between stakeholders that do not want to be held responsible for problems and long delays before supplies can be reallocated to sites with large subject enrollment. 

Research Sites That Find Themselves Making Elementary Mistakes

Shipping regulations, schedules, and requirements change constantly. With a lot of other things to do, research site staff can’t be sure of having the updated information. 

You are someone who needs clinical supply chain management optimization if:

  • Sites ship biological specimens to the wrong lab
  • Sites ship biological samples to the right lab, but on a day they are not receiving, or outside of receiving hours 
  • Sites use the wrong shipper for a biological specimen
  • Sites fail to combine biological sample shipments in a way that could save money
  • Sites are not ready when the courier arrives to pick up a biological specimen

Having a standard operating procedure for maintaining addresses, hours, and requirements eliminates biological specimen loss and damage. This helps ensure the maximum number of biological specimens reach their destination in the desired condition.

Research Sites That Find That The Right Supplies Are Unavailable When Needed

Ordering different supplies required by a research site can require different procedures, contacts, and often even budgets. 

You are someone who needs clinical supply chain management optimization if you have trouble coordinating:

  • Investigational products (IP) from the pharmaceutical company
  • Lab kits from the vendor
  • Delivery and service for calibrated equipment
  • Obtaining and tracking the shippers appropriate to the biological specimens being sent to the analytical laboratory
  • Other supplies, both general and those specifically for this clinical trial, from a variety of vendors

Research sites often run short of essential supplies because:

  • They didn’t take long lead times into account
  • Don’t track which patients are coming in for procedures that require specific lab kits based on their timepoint
  • Don’t know that lack of one supply would make others unusable

This reduces the number of biological samples that can be taken, and thus the eventual amount of the necessary data.

Sponsors That Can’t Get Clear Communications From Other Stakeholders

While clinical trials generate data as their end product, the data available for clinical trial operations is often unavailable, inadequate, or out of date. Most sponsors have to poll research sites by phone to update their own data, and have no access to other data that might be useful. 

You are someone who needs clinical supply chain management optimization if:

  • You rely on phone calls and emails to update your data
  • You have to update individual spreadsheets manually
  • You have to rely on certain employees for processing data, and their absence or departure can lead to data inaccuracies and delays
  • You have to wait a week or more before you can get data on activities at each research site and how subjects are progressing through the trial
  • A staff departure results in a hunt for the data they were maintaining

Without a shared view of the data, errors, update delays, and lost data are inevitable. The impact of this can range from failing to detect serious problems at a research site or analytical laboratory before they become serious, enduring delays while someone reconciles or cleans the data, and an inability to improve inefficient processes.

How to Optimize Clinical Supply Chain Management

If you have identified with some or all of the issues outlined above, there is a software-enabled solution that helps each stakeholder in a clinical trial effectively see, track, manage, and communicate what they need, what activities they need to perform, and what shipments they need to make.

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. Oncology, rare disease, and gene therapy clinical trials are excellent examples of studies that benefit greatly from the Slope eCSCM platform. 

The Slope platform:

  • 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,

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This is the first of a series of five blogs on the topic of clinical supply chain management optimization. Future blogs will cover:

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