Web-based data capture
Custom-made EDC solutions
Lambda-Plus has developed a user-friendly ICH GCP and FDA 21 CFR part 11 compliant on-line data capture tool using forms in PDF format. These forms are available through an extremely intuitive and user-friendly interface and can be accessed through a completely secure environment. Known as an e-Platform this environment is used to display the content differently, according to the user’s profile, whether that user is a physician-investigator, project coordinator, CRA/Monitor, data manager etc.
Lambda-Plus on-line data capture in PDF forms is the most appreciated technique by far, for three different reasons:
• No training required: every user can understand the entry environment in less than 2 minutes
Intuitive solution
• The CRF pages displayed on the screen are the same as those printed out
Easy filing
• No software has to be installed
- Customized eCRF and e-Platform
- Inconsistencies displayed in eCRF for easier correction
- Integrated on-line randomization (IWRS) linked to drug supply management
- On-line monitoring and query management by the CRAs/Monitors
- Automatic notification of side effects for pharmacovigilance department
- Access to profile-dependent on-line reports
- Integration of lab data, avoiding all tedious re-encoding of data