Smart Trial Suite

Smart Trial Suite (Late Phase CTMS) is a clinical trial management software developed by Sarjen Systems for managing late-phase clinical trials. It is designed to reduce operational costs, accelerate trial execution, and support compliance across the full trial lifecycle. The platform uses protocol-adaptive configuration and automation to support diverse trial requirements, from patient recruitment through data collection and document management.

The suite is built around a central Gateway that provides access to multiple integrated modules, each addressing a distinct area of late-phase trial operations. It targets clinical research organisations, sponsors, and site teams requiring coordinated tools for data capture, patient management, regulatory documentation, and real-time oversight.

Core Modules and Capabilities

• IPSM (Investigational Product Supply Management): Handles IP dispensing and management, including real-time drug inventory tracking, automated reordering and expiry management, and site-to-CRO collaboration.
• PM Dashboard: Provides clinical trial data representation and reporting through real-time visual project insights, role-specific metrics, site tracking, and integrated study milestone dashboards.
• PRMS (Patient Recruitment and Management System): Supports patient recruitment and randomisation with dynamic enrolment, stratified randomisation, visit scheduling with real-time alerts, and a full audit trail for every query raised.
• eTMF (Electronic Trial Master File): Manages clinical trial document upload and review through a centralised, compliant document repository with version control, role-based access, and automated workflows with audit trails.
• EDC LP (Electronic Data Capture – Late Phase): Handles clinical trial data and information gathering, supporting direct data capture from devices, real-time edit checks and validations, and role-based access with page reviews.
• ePRO (Electronic Patient-Reported Outcomes): Manages patient questionnaire entry and review, offering patient diaries with multilingual access, flexible surveys with real-time syncing, and engagement tools to support patient retention.
• MI LP (Medical Imaging – Late Phase): Supports image uploading and analysis, including DICOM uploads with secure transfers, lesion measurement tools, and multi-role grading and annotation capabilities.
• PDMS (Protocol Deviation Management System): Covers protocol deviation entry and review, with automated alerts for deviation logging, categorisation by type and severity, and root cause analysis with CAPA tracking.

Platform Features

• 21 CFR Part 11 and GCP compliant
• Globally aligned and audit-ready
• Fast setup with return on investment achievable in under 12 weeks
• Automated and intelligent workflows to support operational productivity
• Protocol-specific configuration to match individual study requirements
• Designed for scalability and reliability across trial sizes and geographies

Integration and Ecosystem

• Smart Trial Suite is part of a broader portfolio from Sarjen Systems that includes solutions for early-phase trials, bioanalytical LIMS, pharmacovigilance safety databases, eCTD publishing, regulatory information management (RIMS), electronic computer system validation (eCSV), quality management, pharmaceutical manufacturing execution systems (MES), and supply chain management.
• The platform supports real-time sponsor collaboration and provides centralised insights across sites and study milestones.

Smart Trial Suite is offered by Sarjen Systems and is available for demonstration. The platform is configured per protocol and is positioned for deployment across organisations requiring a compliant, scalable CTMS for late-phase clinical research.