Notifications
Back


With Maven CDMS® at its center, Maven Clinical Cloud consists
of features and services essential for the most effective clinical trial operation.

With Maven CDMS® at its center, Maven Clinical Cloud consists
of features and services essential for the most effective clinical trial operation. 

Maven CDMS

With EDC as its cornerstone, Maven CDMS® provides various features for clinical trial operational excellence.

Features

  • Maven EDC
    A cloud-based clinical data collection and monitoring system
  • Maven Trigger
    Auto / Manual Query system
  • Maven Coder
    Medical coding with global medical coding dictionaries
  • Maven RTSM
    Randomization and IP management system
  • Maven Auditor/Auditor+
    Blockchain-based audit trail

Value Proposition

  • Hyper Connectivity
    Increased data utilization through flexible integration with various technologies and data based on open API
  • Seamless Journey
    Modular structure allows full customization to fit all clinical trial designs
  • Data Secured
    Tamper-free data protected by blockchain-based audit trail

Maven eCOA

Maven eCOA® is a web-based survey system to efficiently communicate with and collect data from subjects. 

Features

  • Accessibility
    Simple authentication via link through SMS 
  • Identification
    Third party user verification options
  • Customizability
    Fully customizable questionnaires and surveys
  • Connectivity
    Real-time connection with Maven CDMS®

Value Proposition

  • Improved Access
    BYOD to increase user accessibility
  • Enhanced Data Stream
    Real-time and actionable data collection and monitoring
  • Flexible Integration
    Bespoke eCOA customizable with different scales, visuals, and methodologies

Maven Docs

Maven Docs® is a clinical trial document management solution that accompanies a documents lifecycle from writing to reviewing and approving. 

Features

  • Document Viewer
    Document viewing and sharing with enhanced security options
  • eSign
    Electronic signature function optimized for clinical trials (21 CFR Part 11 compliant)
  • Archiver
    Secure storage and sharing of clinical trial documents
  • eConsent
    Provides consistent consent management even in non-face-to-face environments by digitizing the subject consent process

Value Proposition

  • Digital Assetization
    Digitalization of clinical trial documents facilitates data integration with related documents and other systems
  • Regulatory Compliance
    Support for digital signatures and audit response based on 21 CFR Part 11 compliance
  • Patient-Centric Experience
    Provides a patient-centered clinical participation environment based on eConsent
  • Secure Collaboration
    Provides document sharing and access control in a secure environment

Maven Safety

Maven Safety® is a pharmacovigilance solution for the management of adverse event from documentation and collection to exporting and agency reporting. 

Features

  • Data structure design based on ICSR (Individual Case Safety Report)
    Pre-loaded with international standard coding for MedDRA, WHO-DD, EDQM, etc.
  • Electronic reporting based on ICH E2B(R3) and compliance with requirements of major regulatory agencies such as MFDS and FDA
    - Provides real-time case verification based on agency-specific validation rules
    - Direct case transmission to regulatory agencies via Gateway
  • Provides medical device adverse event input function
    - Integration with Maven CDMS (eCRF)
    - Automated collection of adverse events and case creation based on eCRF data
  • Visualization of case status and processing progress via Dashboard
    Real-time monitoring and management of the entire case lifecycle
  • Case lifecycle management via Workflow
    Data Entry -> Quality Review -> Medical Review -> Submission
  • Reporting Function
    Generation of periodic reports such as DSUR and PSUR, as well as custom reports
  • Audit Trail
    Provides an Audit Trail for 21 CFR Part 11 compliance
  • Signal Detection
    Provides potential safety signal detection capabilities

Value Proposition

  • Digital Assetization
    Structuring adverse event data to utilize it as a long-term data asset

  • Built-in Compliance
    Internalizing E2B (R3) and major regulatory requirements as built-in system functions

  • Accurate Data Capture
    Automatically collecting adverse event data and ensuring reliability through integration with Maven CDMS (eCRF)

  • Automation-Driven Safety
    Transforming manual-centric PV processes into automated ones

  • Regulatory Readiness
    Providing a structure that enables immediate regulatory compliance without separate implementation

  • Process Simplification
    Enabling compliance with global regulatory requirements and processes without the need for high-cost solutions

Maven Builder

Maven Builder is a user-friendly clinical trial database design solution that optimizes both study productivity and stability. 

Features

  • Preview
    Provides an intuitive CRF preview 
  • Library 
    Templates verified for repeated use to enhance development speed
  • Sandbox Environment 
    Offers a separate testing environment that does not affect ongoing studies
  • Organization
    Supports study management at the company/team level

Value Proposition

  • Polymorphism 
    Efficient development and operation for all clinical trial designs
  • Stability 
     Ensure independence of design and operation to maximize stability even when modifications occur
  • Productivity
     Increase reusability to reduce the time required for design, verification, and clinical trials

Maven TMF

Maven TMF digitizes Trial Master Files, making clinical trial document storage, access, and management faster and easier

Features

  • Real-time clinical trial document viewing, sharing, and tracking
    - Cloud-based system allowing access anytime, anywhere    - Automatic tracking of all document change history from the time of upload (Audit Trail)

  • Provision of TMF Completeness and Document Status Reports
    Easy search and metadata-based document classification features

  • Milestone-based Document Completeness Management
    Verification and management of required documents for each clinical trial stage

Value Proposition

  • Inspection Readiness
    Enabling immediate response to regulatory inspections by maintaining the latest TMF at all times

  • TMF Completeness Management
    Ensuring complete documentation through milestone-based essential document management

  • Accelerated Trial Execution
    Improving the speed of clinical trial operations through streamlined document preparation and management

  • Seamless Collaboration
    Providing a real-time document sharing and collaboration environment between Sponsors and CROs

Maven Converter

Maven Converter is an SDTM data conversion solution that transforms and validates raw clinical trial data according to CDISC SDTM standards, ensuring accuracy and regulatory submission readiness.

Features

  • Data conversion compliant with CDISC SDTMIG- Function to configure Datasets & Variables based on SDTMIG version
    - Functions to configure Conversion Factors and SDTM CT
    - Data flow that allows re-performing conversion operations when the Raw Dataset changes

  • Metadata creation compliant with CDISC Define-XML
    Enhances convenience in metadata creation through automatic synchronization

  • CRF labeling function compliant with CDISC MSG
    - Function to prevent color conflicts between labels
    - Synchronization of labeled pages with metadata

  • Completion of CDISC standard verification
    CORE Engine-based SDTM verification + Define-XML exhaustive rule verification


Value Proposition

  • Seamless Compatibility
    Transforms data sets generated from all EDCs to conform to SDTM standards
  • Flexible Data Transformation Methods

    Allows users to transform data in a convenient manner through flexible transformation capabilities

  • Seamless Sync Between Transformation Settings and Metadata
    Minimizes manual work by automatically synchronizing data transformation settings with metadata

  • End-to-End Solution from Raw Data to Submission-Ready Files
    A solution that supports the entire SDTM data transformation and verification process from raw data to submission

  • No-Code Based Data Transformation Tool
    Provides an intuitive UI that enables data transformation with just a few clicks