Benefits

SELTA-WAVE: Automating Safety Data Entry Empowering professionals to focus on what truly matters Delivering enhanced productivity for team members Optimizing workforce management and cost efficiency for executives

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

Maximize efficiency by assigning PV experts to specialized tasks, not manual entry.

CSV Compliance

Use a professional program instead of Excel for better usability and security.

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

Converting MFDS KAERS RAW DATA to XML format for global partners or Safety Database upload

Scenario 2

Transform partner-submitted CIOMS REPORT into structured data Automate upload into your corporate Safety Database

Scenario 3

Converting clinical trial SAE Reports to XML format for Safety Database upload or regulatory submission

Scenario 4

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.

Details

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.