Signal Automation
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Reviewer-Friendly Signal Management
Built for PV teams who need structured, explainable, and inspection-ready signal review workflows.
VigiCore Signal Automation helps pharmacovigilance teams standardize internal signal outputs, gather supporting evidence, prepare Signal Evaluation Reports, and generate SRC-ready discussion packs with reviewer control and audit traceability.
SER Preparation
Preparing a Signal Evaluation Report often means pulling together internal outputs, case-series checks, literature review, public evidence, reviewer comments, and historical run context. VigiCore brings these materials into one guided workspace so reviewers can draft, edit, and finalize SER content with less manual stitching.
SER preparation should support reviewer thinking, not add more document assembly work. VigiCore helps standardize the way evidence, interpretation, and draft sections come together so teams spend more time on review and less time rebuilding the same content manually.
SRC Readiness
Signal Review Committee meetings need clear, decision-focused summaries, not scattered spreadsheets and disconnected evidence files. VigiCore helps teams prepare structured briefing packs that summarize the selected signal concept, available evidence, missing information, reviewer comments, and proposed discussion focus.
VigiCore helps teams prepare for internal review conversations with more consistency. The aim is not to pre-decide outcomes, but to give committees a clearer basis for discussion, prioritization, and follow-up planning.
Reduced Manual Burden
PV reviewers should spend their time interpreting evidence, not hunting through files, reformatting tables, or rebuilding the same report sections repeatedly. VigiCore reduces the administrative load around signal review by connecting run outputs, evidence workflows, reviewer comments, report generation, and audit records in one controlled process.
Move from run results to evidence checks, validation, SER drafting, and SRC preparation step by step.
Medical reviewers can add interpretation and recommended actions directly before report generation.
Generate professional Word and PDF outputs with standardized formatting and controlled wording.
Keep internal and external evidence linked to the relevant run and drug-event combination.
Reuse saved run context, evidence summaries, and reviewer comments so teams do not repeatedly rebuild the same content.
Capture key workflow actions and reviewer inputs to support quality review and inspection readiness.
Reviewer Comments
Reviewer comments are often added late in the process, outside the system, or scattered across documents. VigiCore allows medical and PV reviewers to enter interpretation, clinical relevance comments, and recommended next actions directly in the relevant workflow before generating reports.
Saved reviewer comments can be included automatically in Word and PDF outputs, helping teams preserve reviewer context and reduce after-the-fact document editing.
Signal Workflow
VigiCore helps PV teams move from statistical signal outputs to evidence review, interpretation, reviewer-ready documentation, and SRC discussion packs with less manual effort and stronger traceability.
Bring source data into a controlled review flow.
Standardize internal signal outputs for reviewer follow-through.
Move flagged concepts into focused review context.
Document the initial reviewer-facing output clearly.
Bring in internal, literature, and public evidence where needed.
Capture medical and PV comments directly in workflow.
Build reviewer-ready documentation with less manual rework.
Keep the review record structured and defensible.
The workflow is designed to keep users guided without hiding important review decisions.
Reviewers remain in control at each step.
Compliance & Governance
VigiCore helps teams document signal review activities in a structured, consistent, and traceable way. It supports reviewer-led interpretation, evidence organization, and report generation while preserving clear boundaries between statistical outputs, supportive evidence, and medical or regulatory judgement.
The platform supports reviewer work. It does not replace reviewer judgement.
Internal outputs, validation inputs, and external evidence remain structured and attributable.
Supports teams that need clearer, more repeatable documentation outputs.
Key workflow actions and reviewer input remain visible and traceable.
Supports SDR, SER, and SRC-related outputs without making the final decision for the organization.
Designed for MAHs, PV teams, medical reviewers, and signal review committees working at scale.
Closing CTA
VigiCore Signal Automation helps PV teams reduce manual burden, improve consistency, and prepare reviewer-ready outputs for internal signal review, SER drafting, and SRC discussion.
VigiCore helps PV teams move from statistical signal outputs to reviewer-ready documentation, evidence review, SER drafting, and SRC discussion packs with less manual effort and stronger traceability.
The platform is built to support qualified reviewers, not replace medical judgement.
