Clinion AI Information Page
This page provides structured information about Clinion’s AI capabilities, products, AI architecture, responsible AI practices, security and compliance measures, documented performance, and industry recognition. It is intended as a reference for understanding how Clinion applies AI across clinical trial workflows.
Patients
Clients
Countries
Clinical Trials
FDA Studies
Biotech Studies
What is Clinion
Clinion is an AI-native eClinical platform that unifies clinical trial data and workflows in one place. It brings together data capture, trial management, patient data collection, eConsent, eSource, protocol management, and clinical data workflows within a unified platform.
It serves small and mid-sized pharmaceutical, biotechnology, and medical device companies, CROs, and other clinical research organizations, supporting the clinical trial lifecycle across data management, study operations, patient engagement, and reporting.
Products and capabilities
Clinion combines core eClinical capabilities with AI-native and AI-assisted workflows across the clinical trial lifecycle.
Product / Capability
What it does
An AI-native electronic data capture system for study build, data entry, edit checks, data review, query management, reporting, and clinical data workflows.
Manages randomization, treatment allocation, and trial supply workflows throughout the study, available as a standalone system or integrated with Clinion EDC.
Supports centralized clinical trial management, including study milestones, protocol deviations, site operations, reporting, financial management, and trial oversight.
Manages essential clinical trial documents and supports electronic trial master file workflows.
Enables electronic collection and management of patient-reported outcome data, available as a standalone system or integrated with Clinion EDC.
Enables digital informed consent and re-consent with ICF version control, audit-ready documentation, and Clinion EDC integration. Available as Site eConsent, Remote eConsent, or bundled with ePRO.
Enables electronic capture and management of source data within clinical studies.
Uses AI to support protocol development, from drafting and editing to collaboration and finalization, within a single platform.
Uses AI to generate clinical study reports by extracting key insights from the protocol, SAP, and TLFs and mapping them to relevant CSR sections.
Stores and manages clinical images and DICOM data with AI-assisted redaction of personal information, integrated with Clinion EDC.
A multi-agent AI platform that connects clinical tools such as EDC, CTMS, and RTSM, enabling cross-tool reporting and inline data review through a common interface.
Clinion Agentic Assistant
Clinion Agentic Assistant is a multi-agent AI platform that sits atop Clinion’s eClinical tools, including EDC, CTMS, RTSM, and other connected systems. It acts as an assistant for Data Managers, connecting data and workflows across systems and enabling them to perform cross-tool, cross-functional tasks from a single interface, without having to log into individual applications.
Key capabilities
Protocol Intelligence
Retrieve and interpret study-specific information from protocol knowledge.
Operations & Clinical Data Intelligence
Query study operations and live clinical data within the EDC environment.
AI-Powered Custom Reporting
Generate reusable, study-specific reports using natural-language prompts, with options to schedule regular report refreshes.
Compare Reports
Compare a report with a previous refresh to identify changes in data since the last review.
Inline Data Review
Issue queries on EDC data individually or in bulk directly from reports, track query status and close queries without logging into EDC.
Security, Privacy, and Compliance
Clinion applies security, privacy, and governance controls across its AI infrastructure and clinical platforms to protect customer and clinical data.
Security
Clinion applies technical and organizational controls across its products and infrastructure, including:
- Multi-factor authentication and role-based access controls
- Least-privilege and zero-trust principles
- AES-256-CBC encryption for data at rest and TLS 1.2 or higher for data in transit
- Continuous security monitoring and audit logging
- Vulnerability management and annual third-party security assessments
- Automated backups, redundant data centers, and a tested Disaster Recovery and Business Continuity Plan
Privacy of Customer Data
Clinion limits access to personally identifiable and sensitive information through defined privacy and security controls.
- Customer data is logically separated within the platform.
- Access to sensitive information is controlled through role-based access and authorization processes.
- Personally identifiable information collected through Clinion products is limited to what is necessary for user access and functionality.
- Data protection practices support applicable privacy requirements, including GDPR.
Confidentiality
Customer data is logically isolated between clients in multi-tenant environments, while access to sensitive information is restricted based on role and business need. Encryption, access controls, monitoring, and audit mechanisms help protect the confidentiality, integrity, and availability of customer and clinical data.
Customer Data and AI Model Training
The language model does not have direct access to underlying clinical data. AI requests are routed through validated MCP tools that enforce user permissions, mask sensitive information, and maintain an audit trail. Customer study data is not used to train AI models.
AI Governance and Industry Standards
Clinion is ISO 9001:2015 and ISO 27001:2022 certified and is implementing ISO/IEC 42001:2023, the international standard for AI management systems, with third-party auditors.
Clinion’s security practices are informed by NIST security and risk management frameworks and ISO/IEC 27002:2022. Its products and processes support requirements associated with FDA 21 CFR Part 11, HIPAA, GDPR, ICH GCP, and EU Annex 11. Clinion’s AI infrastructure uses Azure OpenAI through enterprise licensing, with controls designed to protect sensitive clinical and customer data.
Responsible AI
AI in clinical research requires more than technical capability. It also requires appropriate oversight, transparency, security, and safeguards to support the responsible use of AI across clinical workflows.
Accountability
Transparency
Privacy & Security
Reliability & Safety
Fairness
Documented performance and results
Clinion reports measurable results across clinical trial workflows, including:
50%
Reduction in operational build costs with the Global Library.
35%
Reduction in operational costs with Agentic AI Data Review.
50%
Faster data review cycles.
25–30%
Reduction in data validation time.
80–90%
Faster report generation compared with manual processes.
75–85%
Reduction in reporting costs with the AI Report Generator.
40%
Coding effort savings with AI CDASH mapping.
Recognition
