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 writhing document efficiency is optimizing
- E-signature system for clinical trials that meet 21 CFR Part 11 (FDA regulation)
- Prevention of document leakage by restricting access outside the internal network (IP Whitelisting) and Inserting a watermark
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
