CTMS Explained
What is the difference between CTMS and EDC?
EDC deployments are typically Study focused; some organizations have multiple EDC installations to cater for different study types or due to legacy technology requirements. Investigator Staff enter the actual study data, that would have been recorded on a paper Case Report Form, into the EDC. Each instance of EDC is Study specific and is configured or customized to meet the Study requirements. This distinction that EDC is study based and CTMS is an enterprise solution highlights the difference in user roles and functions performed by each system
In contrast, a CTMS will span all studies running in that organization, regardless of whether paper-based or EDC based.
EDC Functionality and Users
- eCRF
- eDCF
- SAE’s
Users: Investigator Staff, PM’s, CRA’s and Statisticians
CTMS Functionality and Users
- Study Management
- Regulatory document tracking
- Cross Study Investigator database
- Project Management tools
- Lab management
- IRB management
- Supplies management
- Financials
- Time/Expenses
- Resourcing
- Visit report authoring
Users: CRA’s, PM’s, Clinical Operations, Executives and Finance
Data Common to EDC and CTMS
- Subject data
- eCRF data
- Data Query data
The CTMS uses this data to perform tasks which may also result in the data being passed onto other systems for additional processing.
CTMS uses EDC data in several functional areas:
- Investigator payments
- Cross Study metrics
- Project Management
- Cross study reporting and management
- Recruitment forecasts
- Monitoring visit reports
- Sponsor billing (for CROs)
Clinical Force CTMS has designed the GLUE Data Integration Suite specifically to integrated CTMS with EDC, so enabling you to use each solution optimally while gaining the best visibility and efficiencies in your clinical trials.
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