Safe Exchange of Clinical eSAE data to safety database in E2B format
safeXchange is a web-based system for Investigative Sites to send eSAEs electronically to Sponsor (or other intended groups) to replace the paper process. During creation of case, safeXchange will automatically populate any available data from EDC. Site user selects related data from the available data from EDC and enters other additional information pertaining to that eSAE in safeXchange. Upon data validation checks, relevant reviews by corresponding users and other rules applied, data is finally transmitted to Sponsor's safety database through E2B exchange.
Different types of eSAE Cases:
- Death / Life threatening
- Pregnancy/ Overdose
- SAE (non-D/LT)
Key Feature of safeXchange :
- Simple and easy-to-use
- Study Level configurations
- Manage follow ups of adverse events
- Rules driven & hence deep customization possibilities
- Workflows per business process / per study
- Fetch the data from EDC and generate output in XML or E2B or PDF format
- Triggering of emails per study
- Facilitate follow-ups for existing eSAEs
- Push submitted eSAE data to safety database in E2B format and exchange acknowledgements.
- Enable communication between stake holders using documents, comments and alerts.
Key Benefits of safeXchange :
- Eliminates redundant Paper work
- Reduces risk of errors
- Improves Business Outcomes view