Project and Clinical Data Management
Cutting-edge systems + disciplined process for high-quality data
High-Quality Clinical Data
Ultimately, your study is about the data. High-quality clinical data doesn’t result from chance; the methods you use for collecting, interpreting and managing your study data can be the difference between success and failure.
WCCT and Medelis offer cutting-edge electronic data capture (EDC) solutions or the option to use standard commercial systems such as Rave, InForm, iMedNet and Merge eClinicalOS. We can even work with your own system — whatever works best for your cost, timelines and clinical strategy. Regardless of the system, our focus is on the quality and integrity of the data collected.
Clinical data management services include:
- Development of the clinical data management plan (DMP)
- Database design
- Data validation plan preparation
- CRF/eCRF design
- Data entry of CRFs (paper system)
- Data review
- Data queries generation, tracking and reconciliation
- Coding dictionaries generation for AEs (MedDRA) and medications (WHO Drug), and AE and medication data coding
- Data reconciliation
- Data transfer specifications
- Interim analysis
- Database lock
TrialMaster — A Compelling Solution for Electronic Data Capture
WCCT’s TrialMaster™ Electronic Data Capture Suite offers our clients a unique set of capabilities. By providing the most intuitive end-user experience, it has become the most productive study design tool available — with flexible reporting, off-the-shelf integrations and convenient mechanisms for importing and exporting data.
This proven solution offers advanced features that can add breadth and scope to your clinical research project:
- Study-specific edit checks
- Intuitive interface to guide users during the data entry process
- Data for labs, IVRS or any other source able to be directly imported through CSV files or ODM XMLs
- Multi-language capable, allowing sites to view native CRFs
- ePro: direct access that lets subjects enter their outcomes while blinding personal information
- Customizable exports
- Optional SDTM submission-ready extracts upon study lock
- Ad-hoc reporting for live data review
TrialMaster also provides the following services to make your project run more efficiently:
- Advance edit checks
- Global library
- Data grids
- Real-time validations
- Lab normals
- Risk-based monitoring
- Central monitoring
- Go-live SDTM
- Fully customizable exports
Medelis CRO Services
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