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Use Cases & Examples

Discover how organizations use CTWise API to accelerate regulatory compliance workflows.

Semantic Search Use Cases​

1. Protocol Development​

Challenge: Clinical operations team needs to find all FDA and ICH requirements for a Phase 3 oncology trial with adaptive design.

Traditional Approach:

  • Search FDA website manually
  • Download multiple guidance documents
  • Read through hundreds of pages
  • Risk missing cross-references

CTWise Semantic Search:

import requests

# Natural language query
response = requests.post(
    "https://api.ctwise.ai/v1/search",
    headers={"X-Api-Key": API_KEY},
    json={
        "query": "What guidance exists for adaptive trial designs in oncology?",
        "sources": ["fda", "ich"],
        "top_k": 10
    }
)

results = response.json()
for rule in results["results"]:
    print(f"{rule['rule_id']}: {rule['title']} (score: {rule['similarity_score']:.2f})")

Results:

FDA-ADAPTIVE-2019: Adaptive Designs for Clinical Trials (score: 0.78)
ICH-E20: Adaptive Clinical Trials (score: 0.54)
FDA-DMC-2024-DRAFT: Data Monitoring Committees (score: 0.40)
ICH-E9(R1): Statistical Principles (score: 0.35)

Value: Found 4 relevant guidance documents in under 1 second vs hours of manual search.

Challenge: Regulatory affairs needs to verify informed consent requirements span FDA, ICH, and EMA for a pediatric trial.

CTWise Semantic Search:

# Query understands pediatric + consent relationship
response = requests.post(
    "https://api.ctwise.ai/v1/search",
    headers={"X-Api-Key": API_KEY},
    json={
        "query": "What are the requirements for informed consent in pediatric trials?",
        "sources": ["fda", "ich", "ema"],
        "top_k": 5
    }
)

Results:

FDA-INFORMED-CONSENT-2024 (score: 0.56) - Informed Consent Guidance
ICH-E11(R1) (score: 0.50) - Pediatric Population
FDA-PEDIATRIC-2023 (score: 0.44) - Pediatric Study Plans

Why Semantic Search Works:

  • "informed consent" + "pediatric" understood as related concept
  • Returns FDA informed consent guidance AND pediatric-specific ICH guidance
  • Keyword search would miss documents that say "assent" instead of "consent"

3. Safety Reporting Requirements​

Challenge: Safety team needs to understand adverse event reporting obligations across regulatory bodies.

response = requests.post(
    "https://api.ctwise.ai/v1/search",
    headers={"X-Api-Key": API_KEY},
    json={
        "query": "How should serious adverse events be reported to regulators?",
        "sources": ["fda", "ich"],
        "top_k": 5
    }
)

Results:

ICH-E2A (score: 0.44) - Clinical Safety Data Management
FDA-SAFETY-REPORTING-2023 (score: 0.34) - Safety Reporting for INDs
ICH-E3 (score: 0.32) - Clinical Study Reports

4. GCP Compliance Review​

Challenge: QA auditor needs to verify investigator site is meeting GCP requirements.

# Ask about investigator responsibilities
response = requests.post(
    "https://api.ctwise.ai/v1/search",
    headers={"X-Api-Key": API_KEY},
    json={
        "query": "What are Good Clinical Practice guidelines for investigator responsibilities?",
        "top_k": 5
    }
)

Results:

ICH-E6(R3) (score: 0.55) - Good Clinical Practice
ICH-E6(R2) (score: 0.52) - Good Clinical Practice
ICH-E8(R1) (score: 0.39) - General Considerations for Clinical Studies

Integration Patterns​

Pattern 1: Protocol Validation Workflow​

def validate_protocol_section(section_text, regulatory_area):
    """
    Validate a protocol section against relevant regulatory requirements
    """
    # Find relevant requirements using semantic search
    requirements = requests.post(
        "https://api.ctwise.ai/v1/search",
        headers={"X-Api-Key": API_KEY},
        json={
            "query": f"What are the regulatory requirements for {regulatory_area}?",
            "sources": ["fda", "ich"],
            "top_k": 5
        }
    ).json()

    # Return requirements for manual review
    return {
        "section": regulatory_area,
        "applicable_rules": requirements["results"],
        "review_required": len(requirements["results"]) > 0
    }

# Example usage
sections = [
    ("Section 5.1", "informed consent procedures"),
    ("Section 8.2", "adverse event reporting"),
    ("Section 9.1", "statistical analysis methods")
]

for section_name, topic in sections:
    result = validate_protocol_section(topic, topic)
    print(f"{section_name}: {len(result['applicable_rules'])} rules to review")

Pattern 2: Regulatory Change Monitoring​

def check_for_updates(topics, since_date):
    """
    Check for regulatory updates on specific topics
    """
    updates = []

    for topic in topics:
        response = requests.post(
            "https://api.ctwise.ai/v1/search",
            headers={"X-Api-Key": API_KEY},
            json={
                "query": topic,
                "top_k": 10
            }
        ).json()

        for rule in response["results"]:
            if rule.get("effective_date", "") > since_date:
                updates.append(rule)

    return updates

# Monitor key areas
topics = [
    "adaptive trial design guidance",
    "informed consent requirements",
    "data integrity for electronic records"
]

recent_updates = check_for_updates(topics, "2024-01-01")

Pattern 3: Training Material Generation​

def generate_training_module(topic):
    """
    Generate training materials from authoritative sources
    """
    # Get relevant regulatory rules
    rules = requests.post(
        "https://api.ctwise.ai/v1/search",
        headers={"X-Api-Key": API_KEY},
        json={
            "query": topic,
            "sources": ["fda", "ich"],
            "top_k": 10
        }
    ).json()

    # Structure for training module
    return {
        "topic": topic,
        "authoritative_sources": [
            {
                "rule_id": r["rule_id"],
                "title": r["title"],
                "source": r["source"],
                "relevance": f"{r['similarity_score']:.0%}"
            }
            for r in rules["results"]
        ],
        "query_metadata": rules.get("query_metadata", {})
    }

# Generate module on informed consent
module = generate_training_module("informed consent requirements for clinical trials")

Query Optimization Tips​

1. Ask Complete Questions​

Query TypeExampleEffectiveness
Keyword"informed consent"Basic matches only
Question"What are informed consent requirements?"Better semantic understanding
Contextual"What are informed consent requirements for pediatric Phase 2 trials?"Best results

2. Specify Regulatory Context​

# Generic query
"statistical analysis requirements"

# Better: Include trial phase
"statistical analysis requirements for Phase 3 confirmatory trials"

# Best: Include therapeutic area
"statistical analysis requirements for Phase 3 oncology trials with survival endpoints"

3. Use Source Filtering​

# When you know the relevant authority
{
    "query": "data integrity requirements",
    "sources": ["fda"]  # FDA 21 CFR Part 11 specific
}

# When you need international perspective
{
    "query": "GCP investigator responsibilities",
    "sources": ["fda", "ich", "ema"]  # Compare across authorities
}

Industry Examples​

Pharmaceutical R&D​

Use CaseQuery ExampleValue
Protocol Design"Phase 3 primary endpoint requirements for oncology"Align endpoints with FDA expectations
IND Submission"What documentation is required for IND applications?"Ensure complete submissions
NDA Preparation"Clinical study report requirements for NDA"Meet ICH E3 standards

Contract Research Organizations (CROs)​

Use CaseQuery ExampleValue
Site Selection"Investigator qualifications and training requirements"Verify site readiness
Monitoring"Remote monitoring requirements for clinical trials"Adapt to decentralized trials
Audit Prep"Essential document retention requirements"Ensure audit readiness

Medical Device Companies​

Use CaseQuery ExampleValue
Clinical Evaluation"Clinical evidence requirements for medical devices"EU MDR compliance
Post-Market"Post-market surveillance requirements"Ongoing compliance

Clinical Supply Chain Compliance ⭐ NEW​

Combined Use Case: CTWise + SanctionsWise​

For clinical supply chain operations, organizations often need both regulatory rules lookup (CTWise) and vendor/supplier screening (SanctionsWise). This combined approach addresses:

Pain PointCTWise ProvidesSanctionsWise Provides
Vendor qualificationGMP certification requirementsDenied party screening
Export controlExport documentation regulationsBIS Entity List screening
IMP logisticsTemperature control requirementsDestination country screening
CMO selectionContract manufacturer regulationsOwnership/affiliate screening

Use Case: Pharma Clinical Supply Chain​

import requests

# Step 1: Check regulatory requirements for CMO qualification (CTWise)
regulatory_check = requests.post(
    "https://api.ctwise.ai/v1/search",
    headers={"X-Api-Key": CTWISE_API_KEY},
    json={
        "query": "What are GMP requirements for contract manufacturing organizations?",
        "sources": ["fda", "ich"],
        "top_k": 5
    }
).json()

# Step 2: Screen the CMO against sanctions lists (SanctionsWise)
sanctions_check = requests.post(
    "https://api.sanctionswise.orchestraprime.ai/v1/screen/entity",
    headers={"x-api-key": SANCTIONSWISE_API_KEY},
    json={
        "name": "Example CMO Company",
        "entity_type": "organization",
        "threshold": 0.85
    }
).json()

# Combine results for compliance decision
compliance_status = {
    "regulatory_requirements": regulatory_check["results"],
    "sanctions_status": sanctions_check["status"],
    "proceed": sanctions_check["status"] == "clear"
}

Oracle Fusion SCM Integration​

CTWise integrates with Oracle Fusion Supply Chain Management for clinical supply chain compliance:

┌─────────────────────────────────────────────────────────────────┐
│  Oracle Fusion SCM Workflow                                      │
├─────────────────────────────────────────────────────────────────┤
│                                                                  │
│  Supplier Qualification                                          │
│  ├─ Oracle: Get supplier attributes                             │
│  └─ CTWise: Query GMP/GDP requirements for supplier type        │
│                                                                  │
│  Purchase Order Creation                                         │
│  ├─ Oracle: Generate PO for clinical materials                  │
│  └─ CTWise: Verify export documentation requirements            │
│                                                                  │
│  Receipt & Inspection                                            │
│  ├─ Oracle: Record material receipt                             │
│  └─ CTWise: Check lot tracking regulatory requirements          │
│                                                                  │
│  Shipping (International)                                        │
│  ├─ Oracle: Create shipment record                              │
│  └─ CTWise: Lookup export license requirements by destination   │
│                                                                  │
└─────────────────────────────────────────────────────────────────┘

ERP Integration Pattern​

CTWise can be called from any ERP system via REST API:

# Example: Embedded regulatory lookup in procurement workflow
def check_regulatory_requirements(material_type, destination_country):
    """
    Query CTWise for regulatory requirements before procurement approval.
    Called from ERP procurement module.
    """
    response = requests.post(
        "https://api.ctwise.ai/v1/search",
        headers={"X-Api-Key": API_KEY},
        json={
            "query": f"What are {material_type} export requirements for {destination_country}?",
            "sources": ["fda", "ema", "ich"],
            "top_k": 5
        }
    )

    results = response.json()

    return {
        "regulatory_guidance": results["results"],
        "sources_checked": ["FDA", "EMA", "ICH"],
        "review_recommended": len(results["results"]) > 0
    }

Key Regulations for Clinical Supply Chain​

RegulationCTWise CoverageApplication
21 CFR Part 211✅cGMP for finished pharmaceuticals
21 CFR Part 312✅Investigational New Drug requirements
ICH Q7✅GMP for Active Pharmaceutical Ingredients
ICH Q10✅Pharmaceutical Quality System
EMA Annex 13✅Investigational Medicinal Products
EU GMP Annex 11✅Computerized systems validation

Performance Benchmarks​

MetricValue
Average response time380ms
Results returned95% of queries
Highest similarity score0.78
Average similarity score0.41

Next Steps​

  1. Try Semantic Search - Understand the technology
  2. API Reference - Full endpoint documentation
  3. Get API Key - Start building