Design
- Create eCRF forms with the included intuitive graphical designer by drag & drop
- Reuse of all study elements within studies and across studies
- Accelerate study design by utilizing self-contained elements from your library(s): including edit checks, rules, mappings etc.
- Structured approach for the translation of the clinical protocol to the eCRF
- Define mapping to relational database during form design
- Instant preview of study books at any stage during the design process
- CDISC import / export
Testing
- 1-Click deployment from design to testing
- Enables time-saving during the verification process
- Support for all phases of review and verification, including User Acceptance Testing (UAT)
Rollout & Deployment
- 1-Click deployment from design to investigator
- Version control of study design (metadata)
- Deploy study amendments without compromising study database integrity
- Easy rollout of study amendments
- Fine-grained control of study amendments for all sites, specific sites or specific study books
Data Entry and Monitoring
- Rich, intuitive user interface
- Online and offline data entry and monitoring capabilities
- Integrated workflow
- Ability to create bookmarks and comments
- Hassle-free query resolution
- Improved accuracy and reduced 'cleaning' time by the use of edit checks and constraints
- Instant overview of study progress
- Flags and messages promote the interaction between monitor and investigator
- Various reports on study data, monitoring and progress
Data Management
- Use off-the-shelf tools for ad-hoc analysis of trial data (e.g. Crystal Reports)
- Consolidate data from various data sources
- Supports Oracle and MySQL databases
- Easy data transfer to SAS and MS Office applications
- Data format can be defined to match company standards, thereby eliminates the need for additional mapping programs and allows the reuse of existing standard reports
- Database lock to prevent unauthorized changes to the database.
