Clinical Supply Chain Software

Signant Health's Clinical Supply Chain Software provides industry-leading, cloud-based solutions for managing investigational products across the full lifecycle of a clinical trial. Designed for sponsors, CROs, and clinical operations teams running trials of any complexity — from simple single-site studies to large-scale international programs — the platform delivers centralized visibility, end-to-end traceability, and compliance-ready records to eliminate the risks associated with spreadsheets and paper-based processes.

Managing clinical trial supplies is one of the most operationally demanding aspects of drug development. Ensuring the correct quantities are ordered, manufactured, transported, and dispensed to the right participants requires precision at every step. Signant's solutions are purpose-built to help teams forecast, plan, produce, and distribute supplies more accurately and efficiently, reducing the risk of stock-outs, missed milestones, errors, and safety or compliance failures.

Regulatory Compliance and Risk Management

• Designed to meet the updated ICH E6(R3) Good Clinical Practice guideline requirements, which place greater emphasis on risk-based supply chain oversight
• Supports end-to-end traceability and data integrity across all investigational product systems
• Provides audit-ready records to satisfy modern regulatory expectations
• Enables proactive risk management through centralized visibility across the entire supply chain

GxP Inventory Management

• Enables complete management of the end-to-end supply chain within a single, cloud-based system
• Provides full visibility of all inventory levels across sites and depots
• Tracks product genealogy to maintain a complete history of each investigational product unit
• Incorporates quality release workflows to ensure only approved materials are dispensed

Forecasting and Planning

• Minimizes the risk of medication shortages by enabling precise production planning aligned to study needs
• Streamlines investigational product manufacturing processes
• Enhances control and visibility throughout the production and distribution process
• Provides efficient tools to ensure the right amount of supply is manufactured at the right time

Randomization and Trial Supply Management (RTSM)

• Manages study randomization to ensure patients receive the correct investigational products
• Simplifies supply chain logistics and reduces clinical trial supply waste
• Ensures the right patients get the right products at the right time
• Offers quick deployment to support rapid trial start-up timelines

All solutions are delivered via a cloud-based architecture, supporting scalability from the simplest to the most complex international trials. Signant Health's clinical supply chain platform is built to meet today's regulatory requirements while providing the operational control teams need to keep trials on track and compliant.