Maven Clinical Cloud

Maven Clinical Cloud is a suite of clinical trial software products developed by JNPMEDI, a life science R&D company. Centred on Maven CDMS as its core electronic data capture and management system, the platform covers the full range of clinical trial operational needs — from data collection and randomisation through to pharmacovigilance, document management, and regulatory submission.

The suite is designed for sponsors, CROs, and clinical trial teams requiring integrated, cloud-based tools that support global regulatory standards including 21 CFR Part 11, ICH E2B(R3), and CDISC SDTM.

Maven CDMS — Electronic Data Capture and Clinical Data Management

• Maven EDC: Cloud-based module for clinical trial data collection and monitoring.
• Maven Trigger: Supports both automatic and manual query configuration.
• Maven Coder: Provides global standard medical coding functionality.
• Maven RTSM: Manages subject randomisation and investigational product (IP) supply.
• Maven Auditor / Auditor+: Blockchain-based audit trail and change history management.
• Open API-based connectivity supports flexible integration with external technologies and data sources.
• Blockchain-based data storage provides protection against data tampering and falsification.

Maven eCOA — Remote Clinical Data Collection

• Web-based solution for remote collection and monitoring of clinical outcome assessment data from patients and clinical staff.
• Accessibility: SMS link-based authentication for simple subject access.
• Identification: Third-party identity verification with selectable access security options.
• Customizability: Supports a range of clinical trial questionnaires and surveys.
• Connectivity: Integrates collected data directly with the EDC system.
• Supports BYOD (Bring Your Own Device) data collection to improve subject accessibility and participation.

Maven Docs — Clinical Trial Document Management

• Integrated document management solution covering creation, viewing, and approval of clinical trial documents, with electronic signature as a standard feature.
• Document Viewer: Secure document viewing and sharing with enhanced security options.
• eSign: Electronic signature functionality compliant with 21 CFR Part 11.
• Archiver: Secure storage and sharing of clinical trial documents.
• eConsent: Digitised subject consent process enabling consistent consent management in remote environments.
• Supports regulatory compliance through 21 CFR Part 11-compliant audit trail capabilities.
• Facilitates data linkage between clinical documents and other systems through digitalisation.

Maven Safety — Pharmacovigilance (PV) Management

• Dedicated pharmacovigilance solution covering adverse event entry, approval, export, and regulatory submission to authorities including MFDS and FDA.
• Data structure based on ICSR (Individual Case Safety Report), with built-in MedDRA, WHO-DD, and EDQM coding dictionaries.
• Supports ICH E2B(R3)-based electronic reporting with real-time case validation against regulator-specific validation rules and direct gateway submission to regulatory authorities.
• Supports medical device adverse event entry, with integration to Maven CDMS (eCRF) for automated adverse event collection and case creation.
• Dashboard provides real-time visualisation of case status and processing progress across the full case lifecycle.
• Structured workflow covers: Data Entry → Quality Review → Medical Review → Submission.
• Report generation for DSUR, PSUR, and custom reports.
• 21 CFR Part 11-compliant audit trail.
• Signal detection functionality is planned for release in late April 2026.

Maven Builder — Clinical Trial Database Design

• User-oriented study database design tool for building clinical trial data collection forms.
• Preview: Intuitive CRF preview during design.
• Library: Template functionality allowing reuse of validated studies to accelerate development.
• Sandbox Environment: Separate test environment that does not affect live studies.
• Organization: Group-based study management at company and team level.
• Supports all clinical trial design types and ensures independence between design and operational environments to maintain stability during amendments.

Maven TMF — Trial Master File Management

• Digitises paper-based Trial Master Files (TMF) for more efficient storage, access, tracking, and management of essential clinical trial documents.
• Cloud-based system providing access from any location at any time.
• Automatic audit trail tracking of all document changes from the point of upload.
• TMF completeness and document status reporting, with metadata-based document classification and search.
• Milestone-based management of required documents at each stage of the clinical trial.
• Supports real-time document sharing and collaboration between sponsors and CROs.
• Designed to maintain TMF in a current state for immediate readiness during regulatory inspections.

Maven Converter — CDISC SDTM Data Transformation

• Converts raw clinical trial data into CDISC SDTM-compliant format and produces files ready for regulatory submission.
• Supports dataset and variable configuration according to SDTMIG version, with conversion factor and SDTM controlled terminology settings.
• Data flow functionality allows re-execution of conversion when source datasets change.
• CDISC Define-XML compliant metadata authoring with automatic synchronisation between transformation settings and metadata.
• CDISC MSG-compliant CRF labelling, including colour conflict prevention between labels and synchronisation of labelled pages to metadata.
• SDTM validation using CORE Engine combined with comprehensive Define-XML rule validation.
• No-code interface allows data transformation through an intuitive UI without programming.
• Supports data from any EDC system, covering the full process from raw data to submission-ready files.

All Maven Clinical Cloud products are cloud-based and built to support major international regulatory requirements, including 21 CFR Part 11, ICH E2B(R3), and CDISC standards. The suite is offered alongside JNPMEDI's professional services, including AWS MSP service, to support deployment and ongoing operations.