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August 4, 2022

Collaboration Requirements for an eClinical Supply Chain Management Platform

by
Slope

This blog, Collaboration Requirements for an eClinical Supply Chain Management Platform, is the first in a series where we will detail the critical requirements for an eClinical Supply Chain Management platform. For such a platform to properly optimize the clinical trial supply chain it must support requirements that fall into 4 categories:

  1. Collaboration
  2. Real-Time Visibility
  3. Traceable Chain of Custody
  4. Compliance

This blog—the first in the series—will provide a deep dive into the collaboration requirements.

The clinical supplies managed by a supply chain during the course of a clinical trial include lab kits, investigational product (IP), medical devices, ancillary and other clinical supplies, and biological samples. This means there are a number of collaborators involved in making the supply chain work, such as sponsors, contract research organizations (CROs), research sites, labs, distributors, and couriers. This requires a lot of coordination and communication, which is very difficult with the current chaotic and manual processes that involve spreadsheets, notes handwritten on paper, phone calls, and emails. An eClincial Supply Chain Management (eCSCM) platform must be able to replace these manual processes and have capabilities that streamline the coordination of collaborators and the communication between them.

Collaboration Requirements

When a system successfully meets the collaboration requirements for an eClinical Supply Chain Management platform, collaborators in a clinical trial can effectively see, track, manage, and communicate what they need for the necessary activities. This should be achieved through a collaborative workspace that is configurable to streamline communications and keep the various clinical collaborators—sponsors, CROs, research sites, labs, distributors, and couriers—coordinated regarding protocol-supporting best practices for inventory and sample management. Through this collaborative workspace, not only can clinical trial management be more effective, but it can also encourage protocol adherence, improve resource planning, reduce supply waste and costs, and a variety of other benefits as you will see throughout the blog and discussed in detail in our last blog, Four Reasons to Optimize your Clinical Supply Chain Management.

With manual clinical supply chain management, there is often no consistent ordering or inventory management process. As a result, research sites might have too many lab kits, might have supply closets overflowing with unused or expired lab kits, or find themselves without and have to scramble to acquire the required lab kits for immediate use or improvise with components that risk a protocol deviation.

The key to resolving these issues is by streamlining coordination and communication through these collaboration requirements for an eClinical Supply Chain Management platform:

  • Collaborative Workspace
  • Patient Visit Schedules
  • Standard Schema for Procurement Management
  • Shipping Management
  • Shipping Guardrails
  • Shipping Notifications
  • Integration with Other Systems

Collaborative Workspace

The first of seven collaboration requirements for an eClinical Supply Chain Management platform is providing a configurable workspace. This collaborative workspace must keep the various clinical trial collaborators coordinated with best practices for inventory and biological sample management, and that support adherence to the protocol and its amendments.

An eCSCM platform must be configurable to align with the protocol and document the clinical supplies required for each procedure at each time point in the clinical research study. Once configured and in use, the platform must be able to send alerts and notifications to each collaborator pertinent to their role in the clinical supply chain. This workspace, in conjunction with the following collaboration requirements for an eClinical Supply Chain Management platform, streamlines coordination and communication between collaborators, improves the productivity of all collaborators, reduces the human error that can lead to protocol deviations and supply waste, and improves resource planning—both personnel and clinical supplies for all collaborators.

Subject Visit Schedules

Another one of the important collaboration requirements for an eClinical Supply Chain Management platform is that it provides a calendar with subject visit schedules for each research site that notes which procedure is to be conducted for each subject at that time point. This makes it possible for sponsors and clinical research site coordinators to know the site’s inventory needs to meet the demand of upcoming subject visits and procedures. It also provides insight to sponsors on what is going on at the various research sites. This calendar maintains a schedule of past and future procedures for each subject, improving clinical trial data management and biological sample reconciliation.

Procurement Management

It is required of an eClinical Supply Chain Management platform that sponsors can create a standard purchase requisition schema for lab kits, investigational products (IP), and ancillary and other clinical supplies required throughout the trial.

  • Sponsors should be able to define rules for how and when orders should be placed.
  • The online platform must be able to specify which vendors are approved for fulfilling which purchase requests.
  • The platform must provide guardrails on how and when orders should be placed to prevent missed or redundant orders to prevent supply waste.
  • The platform must be able to track all orders placed by sponsors, CROs, research sites, and other collaborators approved to order supplies.
  • The platform must be able to use the patient calendar mentioned in the previous section to create inventory demand data so that the responsible party knows when to place resupply orders to meet the needs of upcoming subject procedures.
  • The platform must provide inventory thresholds that notify the appropriate collaborators when clinical supplies are running low at the clinical research sites and resupply orders need to be placed.

This set of collaboration requirements for an eClinical Supply Chain Management platform reduces costs since everyone is buying the amount truly needed from the proper vendors so that fewer lab kits go to waste. They also contribute to retaining subjects, by making sure research sites always have the clinical supplies they need for each subject visit.

Biological Sample Shipping Management

Along with procuring clinical trial supplies, eClinical Supply Chain Management platforms must be able to capture standard procedures to create guided workflows that ensure research sites ship biological samples to labs safely and correctly.

  • Shipping instructions, shipping label standards, manifest requirements, and routing instructions must be defined in the platform.
  • Guidance on packaging and shipping biological samples must be documented in the system to reduce the potential for human error and spoiled biological samples.
  • Shipping labels with correct routing information for biospecimen packages and itemized lists of content must be generated.
  • Routing instructions for shipping each biological specimen must be provided, assuring every biological specimen is sent to the correct laboratory.

With these features and other eClinical Supply Chain Management platform collaboration requirements, overall cost and the risk of losing or spoiling samples in transit can be reduced.

Shipping Guardrails

Another collaboration requirement for an eClinical Supply Chain Management platform is providing shipping guardrails that ensure anyone who packages and ships clinical supplies or biological samples does so safely and correctly. These guardrails include: 

  • The schedule for any recipient’s receiving and technician working days and hours, so clinical supplies and biological samples are not shipped to arrive when no one is there to receive them
  • Important details like packaging requirements and any temperature requirements for storing and shipping
  • Which clinical supplies or biological samples need to ship separately from others to ensure they reach their destination in good condition
  • Which labs are to analyze each biological sample, so samples get to the correct lab for processing

The guidance of all this documentation provides clinical operations (ClinOps) with more control over trial execution, and removes the chaos and anxiety that clinical research sites often experience.

Shipping Notifications

Once proper shipping conditions are ensured, the eCSCM platform must automatically notify receiving parties that clinical supplies or biological samples have been shipped. The online platform needs to:

  • Notify sponsors that clinical supplies and IP have been sent to research sites
  • Notify sponsors that biological samples have been shipped to laboratories 
  • Notify clinical research sites that supplies and IP have been shipped and are on their way to them
  • Notify labs that biological specimens are on the way for analysis so they can ensure someone is available to receive and analyze the biospecimen

Shipping notifications are among the critical collaboration requirements for an eClinical Supply Chain Management platform because they remove the need for phone calls and emails, and they reduce redundant activities—which improves everyone’s productivity—allowing each collaborator to plan for their next step in the clinical supply chain.

Integration with Other Systems

An eClinical Supply Chain Management platform does not live in a world by itself. There are other systems supporting the clinical trial such as Electronic Data Capture (EDC) and Interactive Response Technology (IRT) systems. It is important that an eClinical Supply Chain Management platform is able to break down data silos—not create another. Therefore integration is the last of our collaboration requirements for an eClinical Supply Chain Management platform. It must support: 

  • Integration with other clinical trial management systems in use, for example, it must be able to send data to an EDC or receive signals from an IRT that a new subject has been enrolled
  • Integration with courier tracking systems, so collaborators can see where the supplies and samples are while in transit and don’t have to rely on emails and other manual processes to know the status of sample shipments

This creates seamless workflows, reduces the number of systems each collaborator has to access, and most importantly, improves data integrity by removing the need for manual transcription from one system to the next.

Optimizing Clinical Supply Chain Management 

The overarching value of eClinical Supply Chain Management platforms is to optimize clinical supply chain management. To learn more, read our previous blogs:

The Slope eClinical Supply Chain Platform 

The Slope eClinical Supply Chain Management platform was designed and developed to meet these collaboration requirements. It includes a collaboration workspace, provides a calendar to schedule subject procedures, provides features to manage procurement and shipping, automates the necessary notifications to relevant collaborators, and integrates into the current digital infrastructure already in use for the clinical trial.

To see a live demonstration, contact us to talk to one of our clinical trial solutions experts.

Read More

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