Maven Clinical Cloud Services

FEATURES

• Data capturing, monitoring, and reporting cloud
  solution for clinical trials including pre-clinical,
  Phase I-III and PMS/PV
•  Auto-scaling cloud solution fits to global scale
  clinical trials with provision of multi language user
  environment
•  Secured single source of data and data integrity
  with new technologies including blockchain and DB
  schemes

HOW IT HELPS?

• Enroll and manage patients easier and faster with e-ICF
• Get ready for CSR with more accurate data analysis
• Can store large clinical data in blockchain based DB vault
• Localization friendly interfaces with multi language support
• Ready-made report forms for sponsors and regulators

FEATURES

• Randomization based on interactive web response system and fully integrated with Maven EDC for data management
• Supply chain management for investigators and CROs to have visibility on trial supplies (e.g., IP, medical devices, etc.)
• Able to systemize all methodologies for randomization
  and can be automati cally applied

HOW IT HELPS?

• Randomization with most developed digital methodologies
• Prevent violations, deviations and potential bias situations
• Efficient stock management of IP & devices on various sites
• Monitoring dashboard for instantaneous stock delivery
• Simultaneous notifications to sponsor and CROs

FEATURES

• Collect clinical trial data conveniently through mobile devices anytime, anywhere
• Provides a web-based information input screen without downloading and installing a separate app. Simply join the clinical trial through an invitation link from the investigators
• Essential solution for conducting DCTs.
  (Decentralized Clincal Trial)

• Able to respond to all types of mobile devices and operating systems of clinical investigators
• Prevention of source of personal information leakage by invoking and processing SMS sending API
• User-friendly UI allows intuitive information input without a user manual
• Prompt notification of non-entry through real-time registration status monitoring

FEATURES

• Integrated setup environment for Maven cloud solutions with flexible configurators for sponsors, investigators and CROs
• Develop eCRF and EDC quicker and more accurately with provision of built-in settings and reference templates
• Seamless trial operation with auto-generated queries based on distributed validation logic and reporting documents

HOW IT HELPS?

• Easily configure eCRF and data management plan
• Secure a full visibility on data entry on Maven solutions
• Shortened time required for eCRF and EDC development
• Fully customizable with data managers’ preferences
• Easy to go back and refine during data entry and analysis

FEATURES

• Define auto-query deployment logics based on
  CRO, Sponsor and DM’s requirements and apply to
  CRFs
• Provide GUI based usability for query generation logic, push alarm setting for recipients, and methods of delivery
• Easily integrated with digital components
  (DTx, AI, etc.) via open API provision

HOW IT HELPS?

• Streamline workflow from the beginning of trial for efficiency
• Configurable issue reporting system to reduce lead time
• Intuitive UI/UX to reduce setting effort for data managers
• Works perfectly with Builder to define actions on EDC/CRF
• Queries resolvable on anytime, anywhere with authority

FEATURES

• Easy conversion from CRF medical terms to global standard medical coding terms (e.g., MedDRA, ATC Index, WHODD, etc.)
• Coding tools embedded into Maven CDMS™ and data managers can stay in a single system for medical coding
• Auto-suggestive medical coding algorithms based on natural learning processing with AI for enhanced coding accuracy

HOW IT HELPS?

• Use coding tools embedded in EDC with dictionary support
• Predictive coding completion via analyzing previous entries
• Bias prevented manual coding entry mode for medical writers
• Compatible with multi-language coding terms for globalization
• Data entry history tracking for coding term validation check

FEATURES

• Maven exclusive blockchain based query validation system to prevent any possibility of bias or data manipulation
• Continuous verification of single source of immutable data and real-time dashboard for regulatory/sponsor audit
• Provide cryptographic hash functions to track access logs of data upload/download and to prevent forgery of sensitive data and reports

HOW IT HELPS?

• Invincible audit trail powered by blockchain validation logic
• Store data for long term with data integrity and immutability
• Secure single source of data with least operational effort
• More efficient audit preparation with data backup on cloud
• Real-time data validation with omnichannel login environment

FEATURES

• Possible to quickly set up clinical documents (Protocol, ICF, eCRF, CSR) through the template creation and management
• By variableizing common contents of clinical trials, the consistency of documents is maintained in related documents
• Prevention of document leakage by restricting access outside the internal network (IP Whitelisting)
• Insert a watermark within the page to prevent photo taking and screen capture

HOW IT HELPS?

• Improvement of overall work quality under the standardized clinical trial documentation principle
• Increased reusability of content created through standard document form
• Securing the consistency of the document format when working with related personnel
• Minimize Human-Error by removing unnecessary redundant input through data linkage