WAVESafety Data Entry & R3 XML Converting
Repetitive Safety Data Entry and Reporting Automate with SELTA-WAVE
WAVEBenefit
Convert various source data to E2B(R3) XML format
ACCELERATED PRODUCTIVITY
AI technology automates routine Safety Data Entry tasks, significantly reducing time spent on mundane activities.
COST-EFFECTIVE SOLUTION
Access essential management functions without the financial burden of implementing a full Safety Database for foreign case reporting.
STRATEGIC DEPLOYMENT
Redeploy your PV specialists from data entry to high-value activities like QC, maximizing departmental efficiency.
COMPLIANCE ASSURANCE
Replace non-compliant Excel spreadsheets with our validated CSV-based professional solution that handles increasing workloads while meeting regulatory and security requirements.
Resources in Practice
Transform diverse resource formats collected during Safety Data reporting into appropriate formats for your destination, streamlining data entry. Specifically for foreign safety cases, you can input and modify KR fields for direct MFDS submission.
Scenario 1
KAERS DATA TRANSFORMATION Converting MFDS KAERS raw data to XML format for global partners or Safety Database upload
Scenario 2
PARTNER CIOMS INTEGRATION Transform partner-submitted CIOMS reports into structured data Automate upload into your corporate Safety Database
Scenario 3
CLINICAL TRIAL SAE MANAGEMENT Converting clinical trial SAE Reports to XML format for Safety Database upload or regulatory submission
Scenario 4
DIRECT FOREIGN CASE SUBMISSION Submitting XML files from international partners directly to MFDS without Safety Database upload
Upgrade overview
TIME & COST REDUCTION
SELTA-WAVE automates Safety Data Entry, boosting productivity for PV professionals while delivering enhanced workforce management and cost efficiency for executives.
ENHANCED REPORTING CAPABILITY
Submit international safety cases in R3 XML format through the WAVE platform, completing all required KR field entries, reporting, and modifications for MFDS submission without additional Nedrug(KR) access.
Detail
Any Source Any Type
Converts diverse resources like CIOMS, SAE reports, KAERS DB, and Foreign R3 XML into standardized R3 XML files. Use converted files to accelerate your workflow: streamline Data Entry by uploading to your Safety Database, or complete KR fields for direct MFDS submission of foreign cases—adaptable to your specific needs.
Try it yourself!
Your trusted Safety Data expert, always by your side! Experience AI-powered Safety Data solutions with a free trial of SELTA-WAVE!