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:
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, suppliers, 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.
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, suppliers, 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, suppliers 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:
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.
For effective clinical supply tracking, these real-time visibility requirements for an eClinical Supply Chain Management platform must be met:
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 is a critical activity for multiple collaborators in a clinical trial—research sites, sponsors, CROs, labs, and suppliers—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:
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.
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:
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.
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:
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.
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:
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.
The amount of data in clinical research can be overwhelming to track, integrate, and analyze using manual processes. Collaborators care about supplier, supplier, 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:
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.
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:
The accessibility requirements for an online platform are important to encourage adoption and consistent usage, improving collaborator productivity and data integrity.
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 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.