DocEX – CLINICAL RESEARCH DATA STRUCTURING
**Category:** Life Sciences Document Processing | **Industry:** Pharma/Biotech
Artificial Intelligence (AI) is revolutionizing industries worldwide, from healthcare to finance. Businesses are rushing to adopt AI to enhance operations, gain insights, and improve decision-making. However, many are discovering a critical issue: without strong governance, AI initiatives can quickly fall short of their potential.
AI governance is the secret ingredient that helps businesses unlock AI’s full power while ensuring security, compliance, and ethical use. In this blog, we’ll explore why governance is vital to your AI strategy and how it can help businesses avoid the pitfalls of AI implementation.
The Challenge
Client maintained 10+ years of clinical trial data in scattered, unformatted Excel files—no standardization, inconsistent definitions, poor regulatory readiness. Manual processing took **weeks** and error rates were high (8-12%).
Solution: DocEX
AI-driven NER + ontology-based data extraction and structuring engine converting raw research into regulatory-ready format.
## Core Capabilities
– **Clinical NER:** Auto-extract dosages, demographics, efficacy %, study methods
– **Ontology Mapping:** Link entities to medical taxonomies (RxNorm, SNOMED-CT, MedDRA)
– **Study Outcome Matrix:** Build structured outcome tables per trial
– **Ingredient-Condition Mapping:** Generate formulation recommendations based on clinical evidence
## AI/ML Components
– **Named Entity Recognition:** Extract clinical terms, dosages, demographics
– **Ontology Matching:** Map to medical standards and taxonomies
– **Study Outcome Matrix:** Structured clinical data compilation
– **Efficacy Scoring:** Evidence-based formulation recommendations
Deliverables
– **Standardized Excel + JSON repositories** with normalized schema
– **Research-backed formulation recommendations** with dosage ranges
– **Traceability** with confidence scores per extracted field
Business Impact
| Metric | Before | After | Improvement |
|——–|——–|——-|————-|
| Doc Cycle | 15-20 days | 2-3 days | **85% faster** |
| Data Entry Errors | 8-12% | <0.5% | **99% reduction** |
| Regulatory Prep | Weeks of rework | 3-5 days ready | **Audit-ready** |
| R&D Iteration | 2-3 weeks | 3-4 days | **80% faster** |
Key Outcomes
✓ **85% faster documentation cycles**
✓ **Regulatory-submission ready structures**
✓ **Strong proof base** for marketing & compliance positioning
✓ **Scalable to formulation decision-making**
Conclusion: Ready to Unlock AI’s Full Potential?
AI is the future, but without strong governance, it can also be a source of risk. By embedding governance into your AI strategy, you can ensure that your AI projects remain secure, compliant, and scalable. The benefits of AI governance are clear: it builds trust, drives innovation, and unlocks AI’s full potential for your business.
If you’re ready to explore how AI can transform your business without the headaches of compliance and security risks, get in touch with FEDER8 today. We’re here to help you unlock the full potential of AI with the power of good governance.
