AI for Clinical Research & Regulatory Affairs
Synthesize evidence across thousands of studies. Track adverse events. Accelerate regulatory submissions to FDA, EMA, and MHRA — with every claim cited.
Built for
Why Healthcare teams struggle today
The problems we see in every healthcare workflow.
- Regulatory submissions to FDA/EMA require meticulous documentation across thousands of pages
- Adverse event reports buried across multiple systems delay safety signals
- Clinical trial data extraction is manual and inconsistent across studies
- Systematic reviews take 6-12 months of researcher time
- Medical literature monitoring at scale is impossible manually
How DocuLens solves it
Purpose-built capabilities for healthcare workflows.
- Clinical trial data extraction (endpoints, sample sizes, outcomes, adverse events)
- Adverse event detection and tracking across studies
- Regulatory submission compliance checks against ICH, FDA, EMA standards
- Cross-study evidence synthesis with source-grounded summaries
- Real-time medical literature monitoring with custom alerts
Healthcare use cases
The most impactful workflows DocuLens powers for healthcare teams.
Systematic Reviews
Problem: Cochrane-grade systematic reviews take 6-12 months and require teams of researchers.
Solution: AI screens thousands of papers, extracts study data, and synthesizes evidence with PRISMA-compliant outputs.
Impact: Cut review time by 75%. Reproducible methodology with full audit trail.
Regulatory Submissions
Problem: FDA and EMA submissions require precise cross-referencing across thousands of pages.
Solution: Automated cross-reference checking, citation validation, and compliance gap detection.
Impact: Fewer agency questions. Faster approval timelines.
Adverse Event Detection
Problem: Safety signals hide in narrative text across thousands of case reports.
Solution: NLP extraction of adverse events with severity classification and aggregation.
Impact: Detect signals weeks earlier. Improve patient safety.
Medical Literature Monitoring
Problem: Staying current with publications in a therapeutic area is impossible manually.
Solution: Custom alerts on PubMed, journals, and conference abstracts with AI-generated summaries.
Impact: Medical affairs teams stay ahead of competitors and regulators.
Document types we handle
Questions you can ask
- ›“What was the primary endpoint result?”
- ›“Compare efficacy across studies in this evidence set”
- ›“What adverse events were reported in Phase III?”
- ›“Summarize safety signals across all trials”
- ›“Which inclusion/exclusion criteria are most common?”
Why Healthcare teams choose DocuLens
Evidence-cited AI
Every answer linked to source. No hallucinations. Audit-ready by design.
Self-serve to enterprise
Try in 5 minutes. Scale to thousands of users with SSO and RBAC.
12 industry packs
Pre-configured terminology, document types, and rule packs for every vertical.
See DocuLens in action
Free trial. No credit card required. Sample documents pre-loaded so you can explore in minutes.