Loftware Cloud Clinical Trials

Loftware Cloud Clinical Trials (formerly Loftware Prisym 360) is a cloud-based labeling and content management solution designed for the clinical trial supplies landscape. It targets CDMOs, CMOs, CROs, pharmaceutical companies, and biotech organizations that require GxP-compliant labeling with accuracy, consistency, and speed. The platform is built to handle the complex structure of clinical trial labels — including variable text, country-specific regulatory requirements, and multilingual content — within a validation-ready environment.

The solution addresses common challenges in clinical supply labeling such as managing out-of-date expiration or dosage information, reducing design and printing timelines, and maintaining compliance with FDA and EU regulations. It supports Just In Time (JIT) printing and packaging models through dynamic label generation, and integrates with systems including Clinical Supply Management (CSM), Enterprise Resource Planning (ERP), and Product Lifecycle Management (PLM) platforms.

Core Capabilities

• Validation ready: Provides documentation, guidance, and support for the validation process, suitable for regulated GxP environments.
• Business controls: Offers visibility and control to support compliance with global regulations, including FDA 21 CFR Parts 11, 810, and 820.
• Content management: Supports structured storage and management of label content, inserts, and packaging information with advanced features.
• Design management: Simplifies label, document, and artwork layout and formatting for clinical trial materials.
• Workflow management: Controls how content is created, changed, and approved through configurable workflows.
• Label and artwork output: Uses smart print management to generate labels dynamically at the point of printing.

Key Functional Areas

• Regulatory compliance: Streamlines label reviews and approvals, and manages label content, inserts, and packaging to support safe and effective use of investigational products.
• Response time improvement: Dynamic label generation enables JIT printing and packaging, reducing the risk of stock overage and labels carrying outdated information.
• Label and booklet design automation: Automates processes to reduce clinical label and booklet design and printing timelines from weeks to hours, while meeting country-specific regulatory and language requirements.
• System integration: Connects with CSM, ERP, PLM, and other data repository systems to retrieve current label data at the point of printing, supporting accuracy and consistency.
• Traceability and centralized control: Maintains integrity of label data and provides visibility over master data assets to support compliance with FDA and EU regulations.
• Global requirements support: Manages regulatory content, phrase, and language requirements across multiple countries included in a study, reducing timescales and preventing errors.

Integration and Compliance

• Supports compliance with FDA 21 CFR Parts 11, 810, and 820, as well as EU regulatory requirements.
• Integrates with Clinical Supply Management, ERP, and PLM systems to ensure label data is current at the point of printing.
• Announced integration with Signant Health for clinical trial labeling workflows.
• Delivered as a cloud-based platform, with documented case studies showing onboarding within weeks for clinical supply organizations.

Loftware Cloud Clinical Trials is deployed as a cloud-based, scalable solution suitable for organizations of varying sizes, including small and medium pharmaceutical and biotech companies, contract research organizations, and academic institutions. The platform has been adopted by organizations such as CalCog Clinical Supply Services and RxSource to support global clinical trial labeling operations.