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:
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.
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:
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.
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:
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.
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:
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.
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:
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.
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:
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 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.