GenerativeX

Industry

Life Sciences & Pharma

AI systems for regulated teams that need traceable output, controlled review, and workflows that survive compliance scrutiny.

From research and clinical development through regulatory submission, commercial launch, and post-market safety, the constraint is not just accuracy. Outputs need source traceability, review ownership, and a workflow that fits how regulated teams already approve work.

Case Study: Medical Review

AI-assisted medical document review

A controlled workflow for AI review, manual review ingestion, comparison dashboards, categorized differences, and Excel export.

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Capabilities

Drug Discovery & Research

  • Literature synthesis with source-linked evidence trails
  • Research protocol drafting and study design support
  • Target, asset, and competitor intelligence workflows

Clinical Development

  • Protocol design support and site feasibility analysis
  • Clinical document drafting support for CSR, IB, and study reports
  • Patient recruitment, retention, and operational analytics

Regulatory Affairs & Quality

  • CTD section drafting with automated cross-reference validation
  • Regulatory submission document assembly
  • Quality event investigation, CAPA support, and evidence packaging

Medical Affairs & Commercial

  • PRC/MLR pre-checks for promotional claims and references
  • KOL identification, profiling, and territory planning
  • Medical information request handling with review controls

Pharmacovigilance & Safety

  • Adverse event case processing and narrative writing
  • Signal detection from literature and databases
  • PBRER and PSUR preparation support

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