CDM Data Quality Application
A CDM-aligned workspace for issue detection, prioritization, traceability and data-driven review
What it does
It is a practical CDM review workflow. • Helps reviewers quickly understand what needs attention, where the issue sits, and who should review it. • Connects summary metrics directly to subjects, sites, domains, rules and source records. • Keeps rule-driven detection, raw-data traceability and AI-assisted exploration in one application. • Creates a common review language across CDM Core, Clinical, Medical Monitor, Coding and Local Lab. • Consolidates business-rule findings into one consistent issue-level view.
Problem solved
Pharma companies typically take a long time to review and resolve clinical issues, especially when they involve multiple domains (EDC, Central Labs, Third-party data). They also have challenges to manage the data quality from the CRO.
Best suited for
Small and Mid-sized Pharma companies
Typical use
Pharma companies can use the CDM data quality tools to quickly identify data issues
Deployment
Consulting Supported
Implementation
A practical view of what it may take to use this product in your environment.
Implementation requirements
- AWS or Azure server
- * A Windows server
- * A Database server
- * An R and R-Shiny Server
Technical considerations
None specified.
Compliance & validation
Product information below is creator-supplied unless ClinExchange explicitly states otherwise.
21 CFR Part 11
Validation & review information
- Validation available: No / not stated
- Security review available: No / not stated
Creator
Thomas Leung
President · TMC Software IncThomas has 30+ years of clinical and statistical analysis experience in the Pharmaceutical Industry. He led TMC in developing clinical data management and monitoring tools to improve clinical development. He also helped clients recruit seasoned Biometric resources, including Biostatisticians, Statistical Programmers, and Clinical Data Managers.