DMC Services
Independent DMC services that move as fast as your trial
By leveraging our innovative DMC-HUB platform and advanced data-monitoring tools, including Dynamic Data Monitoring (DDM) and interactive statistical presentations {iStats}, we execute work within rigorous procedural and quality standards. Our solutions are purpose-built to safeguard participant safety and maintain the integrity of study results, ensuring independence, efficiency, and rigor from the entire trial. Whether you need full committee management or independent statistical support, we offer flexible engagement models powered by our secure, GxP-ready DMC-HUB and DDM solutions, specifically designed for DMC operations.
DMC-HUB: Centralized Documentation
DMC-HUB centralizes study and DMC documents, meeting materials, and outcomes in a secure, GxP-ready, role-based workspace, so teams can manage a document-heavy, data-heavy process with structure rather than fragmentation.
Leverage Advanced Technology to Enhance DMC Oversight
Our patented DynamicData Monitoring solution continuously tracks accumulated safety and efficacy data during the trial. iStats transforms those results into intuitive, interactive dashboards. Together, they give DMC members real-time insight for faster, more confident recommendations.
Expert Data Science and Statistical Support
Our Independent Statistical Group (ISG) serves as your DMC stats hub, generating data packages and TFLs, executing interim analyses, and providing independent statisticians to guide every DMC review.
Full-service of DMC Management and Operations
DMC charters, monitoring plans, and interim analysis plans aligned with protocol objectives, SAPs, and current FDA and global health authority guidance. Committee formation and onboarding, meeting facilitation, and ongoing communication for efficient, documented, inspection-ready DMC activities.
Key Services
Extensive Experience across Trials and Phases
More than 15 years of experience supporting hundreds of DMCs across all phases of clinical development and a wide range of indications.
Exceptional DMC Workflow Management
End-to-end coordination of DMC workflows, with segregated unblinded data paths and strict access controls to protect trial integrity and align with regulatory expectations.
Meeting Minutes and Documentation Management
Centralized management of study and DMC documents with online review and approval to streamline DMC processes and maintain inspection-ready records.
Dynamic Data Monitoring (DDM)
Accumulated safety and/or efficacy data to be visualized on the “trial radar screen” of DDM. It provides full insight for DMC to make informed assessments and recommendations.
DMC Committee Formation and Onboarding
Assist DMC member identification and onboarding from a curated expert network, including agreements, financial disclosures, and role training.
Independent Advisory and Stakeholder Support
Advisory support for regulatory interactions, statistical interpretation, and coordination with sponsors, CROs, and data providers to keep DMC activities aligned.
