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August 12, 2022

Real-Time Visibility Requirements for an eClinical Supply Chain Management Platform

by
Slope

This is the second blog in a series discussing the requirements for an eClinical Supply Chain Management (eCSCM) platform. There are four categories of requirements for an eCSCM platform to be able to optimize a clinical supply chain. These are:

  1. Collaboration
  2. Real-Time Visibility
  3. Traceable Chain of Custody
  4. Compliance 
This blog will explore the real-time visibility requirements for an eClinical Supply Chain Management platform.

Data integrity is a massive concern for sponsors of clinical trials. When sponsors cannot trust data because it is manually transcribed from paper to system—then from system to system— and provided after the fact, the clinical trial’s success can be at risk. Unlike error-prone manual processes, an online platform can provide real-time visibility into the execution of a clinical trial. Data relevant to the role of each collaborator—sponsors, contract research organizations (CROs), research sites, distributors, labs—can be provided in real-time so that each collaborator can identify issues before they become major problems. An eClinical Supply Chain Management platform must be able to automate the tracking and reporting of every activity related to clinical trial procedures, biological sample collection and shipping, and the inventory management of lab kits, investigational product (IP), devices, equipment, shippers, and ancillary clinical supplies.

Real-Time Visibility Requirements

An online platform for clinical supply chain management must provide real-time visibility into the location, status—and next steps for—lab kits, IP, devices, ancillary supplies and biological samples across sponsors, sites, distributors, labs, biorepositories, couriers, and subjects. If the real-time visibility requirements for an eClinical Supply Chain Management platform are met, cost and risk can be reduced, productivity improved, and subject retention increased.

The platform must provide real-time visibility into clinical supply inventory management, or else sites may not have what they need when needed, resulting in a variety of problems. Critical subject procedures or dosing safety checks might be missed, causing a subject to be eliminated or turned away—ultimately leaving them with a negative experience. Research sites might improvise lab kits, risking protocol deviations. Without real-time visibility into execution, distributors may not ship orders on time, labs might not be ready to receive biological samples, and sponsors won’t know when to step in to resolve issues.

The way to prevent these problems is with an online system that meets these real-time visibility requirements for an eClinical Supply Chain Management platform:

  • Clinical Trial Supply Management
  • Supply Tracking
  • Supply Order Tracking
  • Site Activities
  • Replenishment and Shipment Alerts
  • Single System of Record for One or More Clinical Research Studies
  • Real-time Dashboards and Monitoring
  • Accessible Anywhere, Anytime, from Any Device

Clinical Trial Supply Management Requirements for Inventory Management

One of the essential real-time visibility requirements for an eClinical Supply Chain Management platform is providing clinical research sites with automated inventory management that tracks lab kit, IP, device, equipment, shipper, and ancillary clinical supply inventory. When an eCSCM platform tracks both supply levels and supply needs at each research site, they have what they need for every subject visit and procedure. An eClinical Supply Chain Management platform must provide clinical trial supply management through a combination of the capabilities detailed below. When these requirements are met, workflows and communications are streamlined, data integrity increased, and more biological samples are collected correctly and make it to their destination intact. 

Clinical Supply Inventory Tracking 

For effective clinical supply tracking, these real-time visibility requirements for an eClinical Supply Chain Management platform must be met: 

  • All clinical supplies must be tracked, including lab kits, IP, devices, equipment, shippers, and ancillary and other clinical supplies.
  • The current inventory on hand and storage locations must be tracked at each clinical research site, so research sites always know what clinical supplies they have and where they are stored, down to the storage closet and shelf. 
  • The expiration dates of lab kits, clinical supplies, and IP must be tracked, so research sites can implement a data-driven first-in, first-out model of using clinical supplies to reduce waste. 
  • The recalibration dates for medical equipment and devices must be tracked, so they are ready to be used when needed, and deliver accurate, dependable results.
  • The use, disposal, loss, and return of clinical supplies must be tracked to support biological sample reconciliation, Good Clinical Practices (GCP), and the Sunshine Act. 
  • The lot and serial numbers of clinical supplies must be tracked. 
  • The platform must be able to determine replenishment needs for when lab kits, IP, and clinical supplies are below a threshold, so sponsors and research sites know when to place reorders.

With these supply tracking requirements met, an online platform can make clinical trial inventory management simple and worry-free for both research sites and sponsors. 

Clinical Supply Order Tracking 

Clinical supply order tracking is a critical activity for multiple collaborators in a clinical trial—research sites, sponsors, CROs, labs, and distributors—so that the responsible party knows when to order, how to order, and how much to order, ensuring the supplies are on-site when needed. To accomplish this, an eClinical Supply Chain Management platform must be able to:

  • Track the ordering of every item used in a clinical trial, including lab kits, IP, devices, equipment, shippers, and ancillary clinical supplies
  • Track when clinical trial supply inventories drop below a user-defined threshold and notify those responsible to place resupply orders, giving distributors enough time to ship the items without a last-minute rush order
  • Know who the approved suppliers and distributors are for each kind of clinical supply
  • Log when and how resupply orders were placed, by whom, when they are shipped, and when they are expected to arrive, preventing redundant orders
  • An audit trail must log the history of clinical trial supplies from order through storage, consumption, loss, and disposal 

When these requirements for an eClinical Supply Chain Management platform are met, rush-order surcharges are avoided, effective resource planning is possible, and supply waste is reduced—all of which reduce costs.

Site Activity Tracking and Inventory Management

The key to knowing when to order clinical supplies—in the correct quantity, so they will be there when needed, but not go to waste—is to provide real-time visibility into the upcoming demand at each research site and lab. Therefore an online platform must track all clinical research site activities related to subject visits, IP dispensed, lab kits used, and biological samples collected and shipped. To accomplish this, an eCSCM platform must:

  • Maintain a calendar of subject visit schedules and the procedures required by the protocol at each time point
  • Know the clinical supplies needed for every procedure and track when they are used
  • Record the collection of biological samples, when those biological samples were collected, and who registered them

With clinical supply inventory, order, and activity tracking working together, an eCSCM platform can predict demand at each research site and lab, track usage, and forecast when orders will need to be placed.

These real-time visibility requirements for an eClinical Supply Chain Management platform help manage inventory, and reduce waste and cost. They also improve subject retention by ensuring each biological sample is taken correctly at the correct time point. Finally, these requirements help ensure regulatory compliance and protocol adherence, and to streamline biological sample reconciliation.

Replenishment and Shipment Alerts

Staying ahead of clinical supply management using spreadsheets and other manual processes and communications can be challenging. Clinical operations (ClinOps) teams and site coordinators may have to check clinical trial supplies constantly to know when supplies run low. Multiple collaborators may accidentally place the same order. Any problems during shipping may not surface until it is too late to make adjustments. To address these challenges, an online platform is required to:

  • Automatically alert clinical operations teams and site coordinators when clinical supplies need to be replenished
  • Alert collaborators when an order is placed for clinical trial supplies
  • Update collaborators when the shipment is en route
  • Alert collaborators if any shipment is delayed or problems are discovered

These required alerts can reduce supply waste as they prevent redundant orders from being placed by multiple collaborators, because they know when an order was placed. If a problem does surface, collaborators will have time to make other arrangements because they’ve been alerted in time. These are critical real-time visibility requirements for an eClinical Supply Chain Management platform.

Single System of Record for One or More Clinical Research Studies

Using manual processes to manage multiple clinical research studies spread across many research sites is usually chaotic to organize. Real-time visibility requirements for an eClinical Supply Chain Management platform include providing a single system of record for all site activities. An online platform must provide: 

  • A single version of the truth that all collaborators can trust for all clinical supply chain management activities
  • Support for single research studies and sites, as well as multiple research studies and sites
  • A single, central location and standard process for recording clinical trial activity and related data
  • A record of all user access into the platform, providing visibility into the actions taken by different collaborators within the eCSCM platform
  • Consistent set up and use across all studies and sites

As a result of these requirements, all collaborators can trust the data in the online platform which improves data integrity and supports protocol adherence, compliance, and biological sample reconciliation, while increasing productivity. 

Real-time Dashboards and Monitoring

The amount of data in clinical research can be overwhelming to track, integrate, and analyze using manual processes. Collaborators care about supplier, distributor, and site inventories, subject visits and procedures, and biological samples, among other things. Each collaborator may be focused on something different and receiving irrelevant, or otherwise unhelpful data. An online platform must provide personalized data and activity monitoring in real-time through:

  • Persona-based dashboards available for each collaborator to track the things they care about
  • Reports that summarize the data pertinent to each collaborator so they can analyze progression of the clinical trial 
  • Email alerts and notifications regarding the things most important to each collaborator’s role

As part of the real-time visibility requirements for an eClinical Supply Chain Management platform, the dashboard, reports, and alerts allow busy collaborators to focus on the information pertinent to them, making them more effective and efficient.

Accessible Anywhere, Anytime, from Any Device

Site coordinators and clinical operations teams are not stationary. Site coordinators consistently roam their clinics to grab inventory, meet with patients, conduct procedures, label and ship biological samples, and a myriad of other daily tasks. They cannot keep running back to a computer to log every activity, which is why paper is so often used. Sponsor clinical operations teams attend meetings, visit sites, and travel to conferences, keeping them on the move. To meet the real-time visibility requirements for an eClinical Supply Chain Management platform, it must be: 

  • A browser-based, software as a service (SaaS) application that can be accessed on any device via any web browser
  • Viewable and usable on phones and tablets via a responsive, browser-based application

The accessibility requirements for an online platform are important to encourage adoption and consistent usage, improving collaborator productivity and data integrity.

Optimizing Clinical Supply Chain Management 

The optimization of clinical supply chain management is the overall value of eClinical Supply Chain Management platforms. Read our previous blogs to learn more:

Or unlock our Clinical Supply Chain Management Toolkit.

The Slope eClinical Supply Chain Platform 

The Slope eClinical Supply Chain Management platform was developed and designed to fulfill the real-time visibility requirements discussed above. These requirements include management of clinical trial supplies through clinical supply and order tracking, site activities, automatic alerts for shipment and replenishment, a single system of record for one or more clinical research studies, real-time dashboards and monitoring, and accessibility anywhere at any time from any device. 

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

Latest news

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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.