Adverse event data reconciliation
Safety reviewers receive fragmented event records with inconsistent product and case references.
The challenge behind the workflow.
Safety reviewers receive fragmented event records with inconsistent product and case references.
Connect operational and research data with clear purpose, provenance, and access. Help teams prepare reliable evidence for service planning, quality review, research, and administration while keeping clinical judgment with qualified professionals.
Data to bring together
- Event intake records
- Product reference data
- Follow-up case records
Source systems are examples of the data required. Confirm connector availability, permitted access, refresh timing, and the authoritative owner before implementation.
How Genedata supports the work.
Configure one connected workflow, then reuse its mappings, definitions, and review process as the business grows.
- 01
Connect and prepare
Map identifiers and preserve event dates, source provenance, and follow-up history.
Build the preparation as a reusable visual workflow or reviewed code, with explicit source mappings and validation checks. - 02
Investigate and validate
Highlight duplicate candidates and missing evidence for safety-team assessment.
Keep shared definitions and source versions with the analysis so another team can reproduce the result. - 03
Publish and review
Publish a controlled review pack with clear completeness status.
Make the output available to the right people with appropriate access, ownership, and review evidence.
A safety event review dataset
Make the next run easier.
Reusable reconciliation reduces manual case collation for safety reviewers.
Start from one approved example. Save the agreed mappings and definitions, publish the reviewed output, and let the next team follow the same evidence instead of rebuilding the preparation.
Measure your own improvement
Time preparing complete safety review records
Record a baseline before the pilot and compare like-for-like work afterward. Results depend on source quality, configuration, and adoption.Review and responsibility
Qualified safety teams assess events and determine any required actions or reporting.
AI with professional judgment.
Use AI to organize evidence and draft summaries for review. Clinical interpretation, patient care, and research eligibility decisions remain with qualified professionals.
Try the workflow with your team.
Use representative, approved sample data. Agree the expected output and a review owner before extending the workflow to a live process.