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AI-Powered Life Sciences Document Generation

RegX helps life sciences teams prepare, review, manage, and maintain critical outputs across the study lifecycle. The platform supports protocols, ICFs, eConsent content, ICSR and SUSAR outputs, case narratives, operational files, and CSR drafts in one governed workspace.

 
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From Manual Preparation to Controlled Content Generation

Life sciences teams often work across separate templates, disconnected inputs, manual review cycles, and scattered source materials. This creates delays, rework, inconsistent language, and limited traceability. RegX brings generation, reuse, review tracking, version control, and audit history into one structured environment.

 
Regulatory Automation

Manual Preparation Effort

Reduce time spent creating protocols, consent content, narratives, safety outputs, operational files, and CSR sections.

Disconnected Source Inputs

Keep study details, safety information, consent language, and reporting content aligned across related outputs.

Inconsistent Review Process

Coordinate reviewers, comments, approvals, and version updates through a controlled workflow.

Limited Traceability

Link generated sections to source inputs, review decisions, approval history, and audit records.

Slow Output Readiness

Move from initial draft to review-ready content faster with reusable sections and structured templates.

Everything Teams Need to Generate, Review, and Manage Regulated Outputs

Protocol Generation

Prepare structured protocols using guided inputs, controlled templates, and reusable study information.

  • Protocol Draft Generation
  • Study Design Sections
  • Objectives and Endpoints
  • Eligibility Criteria
  • Schedule of Assessments
  • Version-Controlled Outputs

Prepare and maintain operational files using standard templates and controlled version history.

  • Study File Preparation
  • Template-Based Content
  • Study-Level Reuse
  • Output Assembly
  • Version Management

Support case-level safety documentation for individual safety reports and serious unexpected adverse reaction workflows.

  • ICSR Output Support
  • SUSAR Output Support
  • Case-Level Content Assembly
  • Safety Review Inputs
  • Traceable Output History

Manage multiple output types from one connected workspace across study, safety, and regulatory operations.

  • Multi-Output Workspace
  • Reusable Content Blocks
  • Approved Content Library
  • Output Tracking
  • History Management

Maintain a clear connection between generated content, source records, review comments, and final approvals.

  • Source-to-Output Links
  • Protocol-to-CSR Traceability
  • Audit Trails
  • Review History
  • Content Lineage
ICF & eConsent Content

Create informed consent and eConsent content using study-specific information and participant-friendly language.

  • ICF Generation
  • eConsent Content Support
  • Participant-Focused Language
  • Study-Specific Consent Sections
  • Review and Approval Tracking

Create clear case and safety narratives using structured inputs from safety, medical review, and source records.

  • Case Narrative Generation
  • Safety Narrative Support
  • Medical Review Inputs
  • Structured Narrative Outputs
  • Review-Ready Drafts

Prepare CSR content using protocol details, study summaries, approved sections, and review inputs.

  • CSR Section Generation
  • Protocol-to-CSR Reuse
  • Study Summary Content
  • Results Narrative Support
  • Review-Ready CSR Drafts

Coordinate medical, safety, regulatory, and SME reviews with clear ownership and approval control.

  • Reviewer Assignment
  • Comment Resolution
  • Version Comparison
  • eSignatures and Approvals
  • Approval Dashboards

From Source Inputs to Approved Outputs

Collect

Bring together study details, safety information, protocol inputs, review notes, and output requirements.

Generate

Create protocols, ICFs, eConsent content, narratives, ICSR and SUSAR outputs, operational files, and CSR drafts.

Reuse

Apply approved language, standard sections, templates, and study-level content across related outputs.

Review

Route content to medical, safety, regulatory, and SME reviewers for comments and updates.

Approve

Manage version history, eSignatures, approvals, audit trails, and final readiness.

Publish

Finalize approved outputs for study operations, internal use, submission support, or downstream workflows.

Faster Generation with Stronger Control and Consistency

Faster Turnaround

Reduce manual effort and move key outputs into review faster.

Better Content Consistency

Keep protocol details, consent language, safety narratives, and CSR sections aligned.

Stronger Reuse

Use approved content, standard language, and prior sections across related outputs.

Improved Review Control

Track comments, versions, approvals, reviewer actions, and status in one place.

Clear Traceability

Connect generated content to source records, study inputs, review decisions, and approval history.

Reduced Rework

Minimize repeated preparation, copy-paste errors, formatting issues, and inconsistent updates.

Better Study Readiness

Give teams faster access to protocols, consent content, narratives, safety outputs, and CSR drafts.

Audit-Ready Records

Maintain history, approval records, traceability, and controlled evidence.

Built for Study, Safety, Regulatory, Medical Writing, and Operations Teams

Study Operations Teams

Prepare protocols, consent content, operational files, and study materials.

Medical Writers

Create protocols, CSR sections, narratives, summaries, and structured regulated content.

Safety Teams

Support ICSR, SUSAR, case narratives, safety review inputs, and related outputs.

Regulatory Affairs Teams

Review content for consistency, readiness, traceability, and submission support.

Medical Reviewers

Review narratives, safety content, study language, and medical accuracy.

Study Teams

Use approved protocols, ICFs, eConsent content, and operational materials during execution.

Reviewers & SMEs

Comment on drafts, validate content, approve sections, and track assigned reviews.

Leadership Teams

Monitor progress, review status, readiness, and operational bottlenecks.

Create Submission-Ready Life Sciences Documents with RegX

Prepare protocols, ICFs, eConsent content, ICSR and SUSAR outputs, narratives, operational files, and CSR drafts with AI-assisted generation, content reuse, review control, and source traceability.

 
 
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