CIMS Global


CIMS Global specializes in delivering innovative data science services and solutions for clinical trials. They leverage proprietary and advanced technologies, including AI, Large Language Models, and Machine Learning, to accelerate and improve the quality of clinical trial data processes, analysis, and regulatory submissions. With over 16 years of industry experience, CIMS partners with top pharmaceutical companies and CROs to advance trial progress and generate favorable outcomes, offering a suite of innovative solutions such as DDM, eBinder, and DMC-HUB to reshape the future of clinical trials.

Industries

cloud-data-services
information-technology-dbca
pharmaceutical
software

Nr. of Employees

small (1-50)

CIMS Global

Somerset, New Jersey, United States, North America


Products

Centralized DMC management platform

A secure, role-based platform for Data Monitoring Committee operations providing project workflows, secure document sharing, scheduling, and integrated statistical visualization.

Dynamic data monitoring statistical engine

AI/ML-engineered statistical engine for dynamic monitoring of clinical trials that visualizes cumulative trial metrics, supports sample-size re-estimation and futility decisions, and enables retrospective trial reconstruction.

AI-powered source-data ingestion tool (eBinder)

Tool to automatically process clinical site source documents and upload structured data into EDC systems, optionally integrated with source-data-capture systems or used standalone.

Interactive statistical review dashboard

R Shiny-based dashboard suite to support dynamic monitoring, produce executive summaries, and provide interactive access to statistical outputs for reviewers and DMCs.

Medical writing workstation (Stats2CSR)

Workstation for medical writers that integrates with tables/figures/listings to review, edit, and generate regulatory reports from statistical outputs.

EDC and study-build services

Study build, configuration and support for EDC systems and other trial platforms, including user access management, edit checks, and validation support.


Services

Consulting and execution services including adaptive and dynamic trial design, dynamic data monitoring, retrospective trial diagnosis, statistical analysis and modeling, RWD processing, and R/Python-based package development.

Management of Data Monitoring Committee workflows, provision of independent statistical oversight or independent data-center functions, and facilitation of DMC meetings via a centralized platform.

Provision of R programmers (contractor or project-based), development and validation of regulatory-compliant R environments, R Shiny application development, SDTM/ADaM creation, and SaaS tools for interactive review and report generation.

AI-based processing of site source documents into structured EDC-compatible data to reduce manual entry and improve data quality; integration with EDC and source-data-capture systems.

Provision of medical coding via an encoder tool and management of randomization and drug supply processes through integrated RTSM services and study-build support on EDC platforms.

Expertise Areas

  • Clinical trial design and adaptive monitoring
  • Data Monitoring Committee (DMC) operations and oversight
  • Biostatistics and statistical monitoring
  • R-based statistical programming and R Shiny application development
  • Show More (4)

Key Technologies

  • R (statistical programming)
  • R Shiny (interactive dashboards)
  • Machine learning and AI for trial monitoring
  • GenAI/large language models for data review
  • Show More (4)

News & Updates

Dynamic Data Monitoring for Ongoing Clinical Trials at the Digital Technology in Clinical Trials Conference, October 13-14, 2022, Hyatt Regency Orange County, California.

Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion with Drift, presented by Peng Zhang and colleagues.

Webinar on monitoring ongoing clinical trials with a dynamic procedure, presented by Dr. Tai Xie.

Data monitoring for Chinese clinical trials of Remdesivir during COVID-19, published in DIA Therapeutic Innovation & Regulatory Science.

Presentation on Dynamic Data Monitoring at the Joint Statistical Meeting in Denver, Colorado, July 27, 2019.

Discussion on how traditional clinical trial data evaluation methods are inefficient and how new approaches can improve success rates.

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