CIMS Global Launches DMC-HUB 1.0: A Centralized Ecosystem for Modern Data Monitoring Committees 

SOMERSET, N.J. - April 14, 2025 - PRLog -- CIMS Global proudly announces the release of DMC-HUB 1.0, a comprehensive, secure, and centralized digital environment designed to support the evolving needs of Data Monitoring Committees (DMCs). In response to latest FDA guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-data-monitoring-committees-clinical-trials)
(see details here: https://tinyurl.com/4x8mr5ur ) on the use of DMC's in Clinical Trials, as well as and industry trends toward adaptive trial designs, multiregional oversight, and program-level monitoring, DMC-HUB offers a fully integrated suite of tools to enhance the safety, efficiency, and scientific integrity of clinical trial oversight.

"We built DMC-HUB to address the increasing complexities of clinical trials, helping sponsors by providing a secure digital environment designed to support the unique and developing needs of Data Monitoring Committees (DMCs)," said Tai Xie, Ph.D., CEO and Founder of CIMS Global. "By integrating real-time statistical visualization, study-specific oversight, and GenAI-enhanced review capabilities, we aim to enhance the safety, efficiency, and scientific integrity of clinical trial oversight."

DMC-Project Management – Study-Specific Oversight

Facilitates organized DMC operations with:

• Predefined Workflows: Structured paths for consistent decision-making
• Secure Document Sharing: Role-based folders and data protection
• Schedule and Communication Tools: Access to meeting logistics and reports in one convenient location
• Secure, Role-Based Access: Role-specific folder access ensures that only authorized personnel can access sensitive data, significantly reducing potential security risks.

DDM (Dynamic Data Monitoring) – Real-Time Statistical Visualization

The DDM system applies innovative statistical techniques to visualize cumulative trial data dynamically through a unique clinical trial "Radar Screen," categorizing data trends as Favorable, Hopeful, Unfavorable, or Futility.

Key Features:

• Automatic calculation of Z-values, B-values, and conditional power
• Sample size re-estimation and futility assessment
• Visualization of trial progression and outcome trends
• Reconstruction of completed trials for retrospective diagnosis

InteractiveStats - Integrated R Shiny Applications

DMC-HUB incorporates Interactive Stats, a suite of R Shiny applications seamlessly integrated into the platform to support data-driven decision-making and enhance stakeholder communication.

Key Capabilities:

• Creating statistical analysis output into an interactive dashboard
• Generating executive summaries for DMCs
• Producing open-session slides for sponsors

DARIA (Data Analysis & Review Intelligent Assistant) – GenAI-Enhanced Review

Now integrated within DMC-HUB, DARIA is a beta-stage, GenAI-powered chatbot designed to assist DMC statisticians and reviewers by enabling intelligent, interactive exploration of clinical datasets.

Key Capabilities:

• Upload and review data from multiple formats, including: .sas7bdat, .pdf, .csv, .xml
• Narrative generation for summary documents and publication-ready outputs
• Chat continuity to support contextual, persistent analysis during review
• Built-in data privacy safeguards and session-level security
• Real-time response optimization using advanced LLM and intelligent decision-making

Security & Risk Management

CIMS-Global prioritizes data integrity and regulatory requirements:

• No data is stored or shared outside of the DMC-HUB environment
• DARIA sessions are fully secure and deleted upon logout
• Risk management plans include an assessment of AI model failure, bias, drift, and interpretability prior to full release