Clinevo OneClinicalTrial Platform

Clinevo OneClinicalTrial Platform is an integrated, end-to-end clinical trial management solution designed for life sciences, pharmaceutical, biotech, and CRO organizations. It supports the full lifecycle of clinical trials, including hybrid and decentralized trial models, and is used by clients across the USA, UK, Europe, Korea, Japan, China, and India.

The platform combines clinical trial operations and quality management capabilities within a single system, with compliance built to meet FDA and EMA regulatory requirements. An integrated Quality Management System (QMS) is available as an add-on module.

Clinical Trial Management Capabilities

• Clinical Trial Management System (CTMS) for overseeing trial operations and administration
• Electronic Data Capture (EDC) for collecting and managing clinical trial data
• eCOA (electronic Clinical Outcome Assessment) for capturing patient-reported and clinician-reported outcomes
• eConsent for managing electronic informed consent processes
• Remote Monitoring (rSDV) to support source data verification conducted remotely

Decentralized and Hybrid Trial Support

• Supports both hybrid and fully decentralized clinical trial models
• Integrates the above capabilities into a single platform to facilitate remote and distributed trial conduct

Integrated Quality Management System (QMS)

• Document Management System (DMS) for controlled document storage and version management
• Quality Management tools covering CAPA (Corrective and Preventive Actions), Change Requests, Deviations, and Audits
• eLearning and Training Management System (TMS) for managing staff training and compliance records

Platform Characteristics

• Cloud-based deployment intended to reduce infrastructure requirements and manual processes
• Automated compliance checks and audit trails to support adherence to industry regulations and guidelines
• Covers the full workflow from initial trial setup through to final reporting
• Includes implementation support, training, and ongoing assistance from the Clinevo team

The platform is positioned as a unified solution for organizations seeking to manage clinical trial operations and quality processes within a single, regulation-aligned system. The QMS module is available as an integrated add-on to the core clinical trials platform.