Personalized Medicine (Cell & Gene Therapy)

S-Clinica's Personalized Medicine module is a dedicated RTSM (Randomization and Trial Supply Management) system designed to manage the complex supply chains associated with Cell Therapy and Autologous products in clinical trials. Built for sponsors running Cell and Gene Therapy studies, the platform provides real-time control and management of every step in the autologous supply chain, from patient sample collection through manufacturing and final product delivery.

The system is fully configurable to sponsor-specific processes and logistics, supporting the unique demands of personalized medicine where materials are both collected from and prepared for individual patients. It accommodates extremely short lead times, complex scheduling requirements, and multi-stakeholder coordination across sites, CMOs, shippers, and regulatory representatives.

Core Supply Chain Capabilities

• Management of extremely short lead times for transportation scheduling
• Real-time management and visibility at every step of the supply chain
• Chain of command, chain of custody, and chain of identity enforcement
• Full tracking of product conduct and delivery
• Scale-up and scale-out support for growing study demands
• Automation of key supply chain processes
• Complex scheduling across collection, shipment, processing, return, and injection
• Product release management and comprehensive reporting

Sponsor-Specific Process Configuration

• Custom supply chain design tailored to sponsor workflows
• Configurable process flows to match operational requirements
• Documentation and template management
• RACI framework definition for role clarity
• Structured communication protocols across all stakeholders

Study Set-Up Phase

• Registration of new studies including study code and key details
• Definition of products and conditions such as acceptable temperature ranges, markers, and activity levels
• Configuration of manufacturing and supply organization details
• User and site registration covering read-only users, site pharmacists, IMP coordinators, CMO users, shippers, QP users for release, monitoring CROs, and sponsor teams
• Optional integration with S-Clinica's IRT and supply forecasting modules at no additional cost

Study Running Phase

• Supply forecasting throughout the active study period
• End-to-end ordering and scheduling covering collection, shipment of materials, processing, return, and injection
• Tracking of requests and orders by authorized users based on sponsor-defined templates
• Consistency checks performed by authorized representatives
• CMO representatives can acknowledge receipt of requests and orders within the system
• Manufacturing acknowledgement and registration of dispatch advice upon product shipment

The Personalized Medicine module is part of S-Clinica's broader ClinVision platform, which also encompasses Clinical Supply Forecasting, Drug and Supplies Management, Direct-to-Patient logistics, Supplies Return and Destruction, and Data Transfer and Integrations. System interfacing with S-Clinica's IRT and forecasting tools is provided at no cost, enabling a fully connected clinical supply ecosystem for Cell and Gene Therapy trials.