Clinion

Clinion is a software company that develops an integrated eClinical platform for sponsors and contract research organizations (CROs). The platform covers the full clinical trial lifecycle, from study start-up through to closeout, and incorporates artificial intelligence across its core modules. Clinion serves clients across multiple countries and supports a range of clinical trials, including FDA studies.

The platform is designed to unify study operations on a single system, reducing the need for multiple disconnected tools. Clinion positions its AI capabilities as built into the platform rather than added on, applying them to tasks such as protocol drafting, data review, medical coding, and clinical study report generation.

Core Products and Modules

• eProtocol: Uses AI to auto-generate ICH M11 and TransCelerate-compliant protocol drafts from study summaries. Supports the full workflow of draft generation, collaboration, review, and finalization on a single platform, with the aim of reducing costs and timelines by up to 60%.
• EDC (Electronic Data Capture): Includes AI-driven automation for study setup, CDASH mapping, remote source data verification, medical coding, data review, and custom reporting. Designed to accelerate trials while maintaining data quality and reducing costs.
• RTSM (Randomization and Trial Supply Management): Automates patient randomization, kit assignment, reassignment, and returns, and integrates directly with Clinion EDC to eliminate the need to log into separate systems. Supports studies ranging from simple to highly complex designs and can be deployed within days.
• eConsent: Provides multimedia informed consent forms with real-time tracking and a patient-oriented interface. Supports both onsite and remote consent, integrates with Clinion EDC, and is intended to reduce site burden and shorten setup timelines.
• ePRO (Electronic Patient-Reported Outcomes): Available as a standalone application or integrated with Clinion EDC. Supports multilingual forms, automated reminders, and data entry via mobile, tablet, or web. Designed for global trial scalability.
• eSource: Enables real-time data capture with built-in validations, full traceability, and EDC integration, supporting clean and compliant data from initial capture through to database lock.
• CTMS (Clinical Trial Management System): Centralizes project tracking, monitoring, and financial management. Integrates with EDC and RTSM to provide real-time operational visibility for CROs and sponsors.
• CSR (Clinical Study Report): Uses AI to extract key information from the Protocol, Statistical Analysis Plan (SAP), and Tables, Listings, and Figures (TLFs), auto-populating up to 70% of the CSR while maintaining ICH E3 compliance.
• eTMF (Electronic Trial Master File): Provides trial document management with pre-built DIA reference models, real-time tracking, version control, bulk upload capability, and audit trails to support inspection readiness throughout the trial lifecycle.

Integration and Deployment

• The platform modules are designed to work together seamlessly, with EDC serving as a central integration point for RTSM, eConsent, ePRO, eSource, and CTMS.
• RTSM can be deployed within days, and the overall platform is described as quick to configure and set up for individual studies.
• ePRO supports mobile, tablet, and web-based data entry, enabling flexible deployment for global trials.

Compliance and Standards

• Clinion states that its platform is fully compliant with global regulatory standards.
• eProtocol supports ICH M11 and TransCelerate protocol formatting requirements.
• CSR generation adheres to ICH E3 guidelines.
• eTMF is built around DIA reference models to support inspection readiness.
• The platform has been used in FDA studies.

Customers and Recognition

• Clinion serves clients including Creative Medical Technology, the Public Health Foundation of India (PHFI), and CBCC Global Research, among others.
• Customer feedback highlights ease of study setup, configurability, and the responsiveness of the support team.
• The company has received awards and recognitions in the clinical trials space, described as achievements in clinical excellence.

Clinion reports that its platform can reduce trial costs by approximately 35% and accelerate time-to-market by approximately 30%, based on figures cited on its website.