Clinical Trial Platform

SyMetric Clinical Trial Platform is a cloud-based, end-to-end platform designed for clinical trials. It offers fully modular tools that can be selected and configured to match the specific requirements of a study, making it suitable for pharmaceutical companies, clinical research organizations (CROs), and academic institutions. The platform supports a range of trial designs including adaptive trials, umbrella trials, basket studies, and virtual clinical trials.

The platform integrates multiple components — including EDC, IRT/IWRS, and CTMS — into a single unified solution, with a collaboration model that provides secure, real-time access to trial data for all teams and individuals involved in a study.

Platform Modules and Tools

• Identity and Access Management: Controls user authentication and authorization across the platform.
• Organization Management: Manages organizational structures involved in a trial.
• Study Management: Supports the setup and oversight of clinical studies.
• Site Management: Maintains and tracks trial site information.
• Clinical Supplies Management: Handles the management of clinical supplies across a trial.
• Subject Management: Tracks and manages trial subjects.
• Data Management: Includes a Global Library, Data Designer, Data Validation Manager, Data Collection, Discrepancy Management, Source Data Verification, and Data Exports.
• Lab Management: Supports laboratory data and operations within a trial.
• Medical Coding: Provides medical coding functionality.
• Data Services: Offers additional data-related services.
• Digital Learning: Provides learning resources within the platform.
• Help and Support: Integrated support tools for platform users.

Core Solutions

• IRT/IWRS: An interactive response technology and web response system solution designed to handle complex clinical trial designs, including randomization and trial supply management.
• EDC (Electronic Data Capture): Includes tools that transform data management processes, simplifying and automating data flow and validation in clinical trials.
• CTM (Clinical Trial Master): Provides repositories for maintaining global objects, including trial sites, labs, organizations, and global data libraries.

Key Platform Capabilities

• Fully integrated modular application: IRT/IWRS, CTM, and EDC components are built as a single integrated solution to increase trial efficiency and reduce costs.
• Single Sign-On (SSO): Users can access all authorized tools with a single set of credentials, eliminating the need for multiple logins.
• Reusable forms and business rules: CRFs with standardized data definitions and associated business rules can be imported from a Global CRF Library, reducing form redesign efforts.
• Flexible and customizable: The application design can be tailored to suit all types of research study patterns with minimal configuration changes.
• Real-time reports and dashboards: Customized reports and dynamic dashboards allow tracking and analysis of key performance indicators and site metrics.
• Collaborative environment: The platform provides a virtual collaborative environment that streamlines communication among multiple teams, with fully customizable role-based authorizations for secure, real-time access to trial data.
• 24x7 technical support: Round-the-clock support is provided by a dedicated technical team for issue resolution.

Security and Compliance

• Compliant with 21 CFR Part 11 (US FDA) and ICH-GCP guidelines, featuring procedural controls, audit trails, and electronic signatures.
• Certified to ISO 27001 (information security management) and ISO 9001 (quality management) standards.
• Supports data protection laws and Good Clinical Practice guidelines through defined policies, processes, and a Standard Operating Procedure framework.
• Positions itself as a custodian of client data, with a stated commitment to data privacy and full client control over research data.

SyMetric Clinical Trial Platform is available as a SaaS solution with cloud-hosting options, and supports both dedicated single-tenant deployments and custom deployment models. It is available through the SAP Store and has been deployed for clients across India and internationally.