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Clinical Trial Supply Management (CTSM)

It is a regulatory mandate that all the clinical trial supplies are accounted for by the sponsor. The supply chain underlying a clinical trial is a very complex entity and supply chain managers need not be warned of the myriad of things that may go wrong in their efforts to deliver the right supplies to multiple sites at remote geographic locations. Hence there is a need for an automated supplies strategy that addresses the unique challenges involved in the clinical trial supply chain, that offers more visibility and real-time insights to reduce drug waste and mitigate uncertainty in demand.

Octalsoft’s CTSM helps you efficiently manage the complex tasks of end-to-end clinical trial supplies and logistics processes while ensuring compliance with regulations and Good Manufacturing Practices (GMP). Robust inventory management tools automate the depot management processes of tracking and tracing both regulated and unregulated inventory and shipments, across multiple clinical sites and warehouse locations. Integrated workflows along with email notifications and alerts automate the depot management and distribution processes and enhance inventory visibility and cost tracking throughout the supply chain.

Customs and procurement modules provide the ability to manage other imperative processes seamlessly. The integrated customer portal provides controlled access to your clients to place, track and return orders online, with ease.

Product Benefits

Real-time Inventory Insights

Octalsoft CTSM provides instant oversight over the entire project cycle for clinical trial supply management including scheduling as per demand and supply, distribution, logistics, and costings. It enables traceability of all trial materials including IMPs, NIMPs, and lab kits throughout the supply chain and prevents incidences of “stock-outs”.

Supplies Accountability

The software provides the user with full accountability of used and unused trial supplies held with sponsor, site or third-party depots. It also accounts for a complete reconciliation of drug product at the end of a clinical trial, monitors shelf life and expiry dates, extends expiry dates if applicable, and manages quarantined supplies. The software keeps records in the event of a product recall, lost status, and product return or damage.

Enhanced Visibility

Octalsoft CTSM can be easily integrated with the site’s IWRS system. This provides enhanced visibility of what has been received and what is exhausted at individual site level. Allocation of specific drug kits to patients allows for stock subtractions to be made and the software calculates an exact and accurate inventory remaining at the site. This enhanced visibility means that sites can be maintained with minimum stock levels and replenished just-in-time.

Process Automation

Challenging study variables such as unpredictable and underestimated subject enrolment, adaptive trial designs, changing custom regulations all lead to fluctuating demand signals, frequently causing supply disruptions. Such scenarios require significant human and monetary resources and are difficult to forecast using spreadsheets. Process automation using Octalsoft CTSM not only helps you synchronize ever-changing demand and supply at optimal costs but also enable visibility and agility throughout the entire supply chain.

Time, Labor and Cost Saving

Accurate tracking of clinical supplies maximizes productivity by building a more demand-driven and leaner supply chain aiming for the right products at the right time in the right quantity. It ensures accurate and timely supply of drugs to clinical sites, at optimum cost and with minimal drug wastage.

Product Overview

Complete supply chain tracker

Real-time inventory management

Inventory forecast and optimization

Dynamic supply rules and logic

Integrated barcode scanning and labeling

Customizable by user and role

Integrated billing and financial reporting

Depot management and stock control

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