eClinical Supply Chain Management Platform Requirements

This blog will provide an overview of the four-blog series detailing eClinical Supply Chain Management (eCSCM) platform requirements. The four categories of requirements addressed in the series are:

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

Here we will highlight the key points for each of these eClinical Supply Chain Management platform requirements.

Administering a clinical research study comes with considerable risks to achieving a successful trial. These risks are caused by challenges involving data integrity, budget overruns, collaborator productivity, and subject retention, to name a few. An eCSCM platform should mitigate these challenges and reduce risk by replacing manual processes while fostering collaboration between stakeholders, providing real-time visibility into activities and inventory at research sites, ensuring a traceable chain of custody for biological samples and other clinical supplies, and encouraging stronger protocol adherence and regulatory compliance.

Collaboration Requirements for an eClinical Supply Chain Management Platform

Communication and coordination between sponsors, contract research organizations (CROs), research sites, labs, suppliers, and couriers can be chaotic and inefficient with manual processes for clinical supply and biological sample management. Therefore, an eClinical Supply Chain Management platform must facilitate collaboration.

The capabilities detailed in our “Collaboration Requirements for an eClinical Supply Chain Management Platform” blog are:

• Collaborative Workspace – to coordinate and control how collaborators manage clinical supply inventory and biological samples
• ‍Patient Visit Schedules – to maintain a calendar for each trial subject to ensure that the clinical supplies needed for each protocol procedure and biological sample collection are available
• Procurement Management – to standardize the purchase requisition schema for all research site clinical supplies with schedule-driven fulfillment based on inventory thresholds
• Biological Sample Shipping Management – to capture standard procedures that create guided workflows for shipping each kind of biological sample
• Shipping Guardrails – to reduce the potential for errors when shipping each kind of biological sample and clinical supply
• Shipping Notifications – to automatically alert the appropriate collaborators that clinical supplies have shipped
• Integration with Other Systems – to share data and events with other clinical trial software and to easily track shipments through integrated courier systems

When these collaboration requirements for an eClinical Supply Chain Management platform are met, collaborators in a clinical trial can effectively see, track, manage, and communicate each other’s needs and activities, giving sponsors the coordination and control they need to minimize clinical trial risks.

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

Without real-time visibility into clinical trial execution, sponsors and CROs have no way of knowing how the clinical trial is progressing from site to site on any given day or week. If there isn’t real-time visibility into subject visit schedules and clinical supply inventory, research sites may not have what they need when they need it. This can lead to missed subject procedures, missed safety checks, and sites improvising lab kits with whatever supplies they have on hand, all of which can lead to protocol deviations.

In the blog “Real-Time Visibility Requirements for an eClinical Supply Chain Management Platform”, we discuss preventing these problems by providing collaborators with visibility into research site activities and the location and status of lab kits, IP, devices, and ancillary and other clinical supplies. These requirements are:

• Clinical Trial Supply Management – to ensure that research sites have the clinical supply inventory they need for each subject visit and procedure through digital inventory management
• Clinical Supply Inventory Tracking – to know the amount, location, expiration date, lot and serial number, usage state, and resupply needs of clinical supplies, and recalibration dates for medical equipment and devices
• Clinical Supply Order Tracking – to know when orders are placed, who placed them, when they were shipped, when they are expected to be delivered, when received, and where they are stored
• Site Activity Tracking – to know upcoming subject visits, procedures, and clinical supplies the protocol and associated manuals require at each of those time points
• Replenishment and Shipment Alerts – to automatically notify collaborators when clinical supplies need to be reordered, when an order is placed, when the shipment is en route, and if there are any problems
• Single System of Record for One or More Clinical Research Studies – to provide one version of the truth that all collaborators can trust for all subject visits and clinical supply chain activities
• Real-time Dashboards and Monitoring – to summarize pertinent clinical supply data and ensure collaborators have insight into all metrics relevant to them
• Accessible Anywhere, Anytime, from Any Device – to provide continual access to the eCSCM platform despite the chaotic, on-the-move nature of research site and clinical operations staff’s days

These real-time visibility requirements for an eClinical Supply Chain Management platform ensure collaborators have up-to-the-minute insights into the status of clinical supplies, next steps to be taken, and how the clinical trial is progressing, so that if issues occur actions can be taken to minimize risk.

Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform

Biological sample collection, handling, storage, coordination, and reconciliation can be time-consuming and prone to mistakes when using manual processes. This can lead to gaps in knowledge of a biological sample’s whereabouts during its lifecycle, which can make its subject non-evaluable and compromise overall data integrity. The clinical trial itself can be at risk if this occurs too frequently.

In the blog “Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform”, we discuss avoiding these risks by ensuring all clinical supplies—including biological samples—can be traced throughout their lifecycle. These requirements are:

• Biological Sample Tracking – to capture data that shows the complete chain of custody for each biological sample and the supplies used to collect and ship it
• Lab Notification – to alert labs automatically when biological samples have shipped along with an electronic shipping manifest and when they will be delivered
• Data-enabled Smart Lab Kits and Clinical Supplies – to automatically track clinical supplies and biological samples throughout their lifecycle, making reconciliation complete, accurate, and easy
• Drug and Device Accountability – to ensure sponsors maintain a record of their IP’s location, administration, and reclamation
• Audit Trails – to track every action by each collaborator throughout the clinical trial, every biological sample collected, processed, and shipped, and every clinical supply used throughout the clinical research study to create a fully traceable chain of custody during reconciliation

These traceable chain of custody requirements for an eClinical Supply Chain Management platform ensure that sponsors can reliably trace biological samples throughout their lifecycle, reducing the risk of unusable biological samples and increasing overall trial data integrity.

Compliance Requirements for an eClinical Supply Chain Management Platform

Referencing protocol manuals can be laborious and prone to error, leading to process delays, workflow inefficiencies, misinterpretations, and mistakes over the course of a clinical trial. In addition, sponsors don’t really know if collaborators are following the protocol or complying with regulations and best-practice guidance. An eClinical Supply Chain Management platform must help collaborators follow the protocol and comply with regulations and best-practice guidance.

The capabilities detailed in our “Compliance Requirements for an eClinical Supply Chain Management Platform” blog are:

• Configurable to Each Study Protocol – to embed the processes and procedures defined in the protocol and associated manuals into the way the eCSCM platform functions
• Support for Protocol-based Workflows – to guide each collaborator to perform their tasks in accordance with the protocol and associated manuals
• Harmonize Activities Across Amendments – to roll out multiple protocol amendments to different research sites at different times in a clean, well-managed way
• Provide Role-Specific Privileges – to delegate access to the eCSCM functions and data according to each collaborator’s role
• Support Regulatory Compliance and Best-practice Guidance – to encourage collaborators to comply with regulatory requirements and best-practice guidance and provide documented verification
• Audit Support Materials – to track that every action taken by collaborators, all activity involving clinical supplies, and each subject’s participation is in agreement with the protocol, regulations, and guidance
• Training and Education – to instruct on the use of an online platform with training, documentation, online help, and on-demand chat assistance

These compliance requirements of an eClinical Supply Chain Management platform strengthen adherence to the protocol, compliance with regulations, and the following of best-practice guidance, and provide sponsors with defensible documentation of this fact.

Optimizing Clinical Supply Chain Management

The optimization of clinical supply chain management is the overarching value of an eClinical Supply Chain Management platform. Read our previous blogs to find out more:

• Who Needs Clinical Supply Chain Management Optimization
• When You Need to Optimize Your Clinical Supply Chain Management
• Four Reasons to Optimize Your Clinical Supply Chain Management
• Collaboration Requirements for an eClinical Supply Chain Management Platform
• Real-time Visibility Requirements for an eClinical Supply Chain Management Platform
• Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform
• Compliance Requirements for an eClinical Supply Chain Management Platform

Or unlock our Clinical Supply Chain Management Toolkit.

Stay tuned for our next blog, “How to Implement an eClinical Supply Chain Management Platform.”

The Slope eClinical Supply Chain Management Platform

The Slope eClinical Supply Chain Management platform was designed and developed to meet the above requirements. These required capabilities include fostering collaboration, providing real-time visibility into clinical supply management, tracing the chain of custody of biological samples and other clinical supplies, and facilitating compliance.

‍Contact us to talk to one of our clinical trial solutions experts to see a live demonstration.