Frequently Asked Questions

Common questions about CTWiseAPI.

General

What is CTWiseAPI?

CTWiseAPI is an API-first regulatory intelligence platform that provides programmatic access to 500+ regulatory rules from FDA, ICH, EMA, and WHO. It is designed for pharmaceutical companies, CROs, and biotech organizations that need to automate regulatory compliance checks for clinical trial protocols. CTWise is available on AWS Marketplace with a 14-day free trial.

Key capabilities:

• Semantic search across all FDA CFR Title 21, ICH Guidelines, EMA directives, and WHO guidance using natural language queries
• FDA 483 Intelligence to analyze inspection observations, facility risk scores, and trending citations
• Version tracking to monitor regulatory changes over time
• Evidence-based responses with citations to original regulatory source documents
• Prevent costly protocol amendments by validating against current guidance

What FDA regulations does CTWise cover?

CTWise provides comprehensive coverage of FDA CFR Title 21, including:

• Part 11: Electronic Records and Electronic Signatures
• Parts 210/211: Current Good Manufacturing Practice (CGMP) for drugs
• Part 312: Investigational New Drug (IND) applications
• Part 820: Quality System Regulation for medical devices
• Part 314: New Drug Applications (NDA)
• Plus hundreds of additional CFR parts covering food safety, biologics, and clinical trials

All FDA regulatory content is semantically indexed for natural language search.

Does CTWise include ICH guidelines?

Yes. CTWise indexes all current ICH guidelines including:

• ICH E6(R2/R3): Good Clinical Practice (GCP)
• ICH E8(R1): General Considerations for Clinical Studies
• ICH E9(R1): Statistical Principles for Clinical Trials
• ICH Q7-Q12: Quality guidelines for pharmaceutical manufacturing
• ICH S1-S10: Safety/nonclinical guidelines

ICH E6(R3), the upcoming revision introducing risk-based quality management (RBQM), is tracked with version comparison capabilities.

How does CTWise semantic search work?

CTWise uses AI-powered semantic search (Amazon Titan Embed v2) to understand the meaning of natural language queries, not just keyword matching. For example:

• Query: "What are the requirements for electronic signatures in clinical trials?"
• CTWise returns relevant sections from 21 CFR Part 11, ICH E6 guidance on electronic records, and related EMA guidance

This is fundamentally different from keyword search — it understands regulatory concepts and cross-references related requirements across authorities.

What is FDA 483 Intelligence?

FDA 483 Intelligence is a CTWise capability that provides:

• Observation search: Search across thousands of FDA Form 483 inspection observations
• Facility risk scoring: Risk profiles for inspected facilities based on citation history
• Trending citations: Track which CFR sections are most frequently cited in recent inspections
• Investigator analytics: Identify inspection patterns by FDA investigator

This helps regulatory affairs teams proactively prepare for FDA inspections by understanding current enforcement trends.

What regulatory sources does CTWise index?

CTWise currently indexes regulatory content from four authoritative bodies:

Authority	Sources	Rules Count
FDA	CFR Title 21, Guidance Documents, 483 Observations	300+ rules
ICH	E-series, Q-series, S-series guidelines	80+ rules
EMA	Scientific guidelines, reflection papers	100+ rules
WHO	Technical guidance, prequalification standards	50+ rules

Total: 500+ structured regulatory rules with semantic indexing.

What data sources does CTWiseAPI use?

We aggregate and structure guidance from:

• FDA: Guidance documents, Federal Register notices, CDER/CBER publications, CFR Title 21
• ICH: Harmonized guidelines (E6, E8, E9, Q-series, S-series)
• EMA: Scientific guidelines, reflection papers
• WHO: Technical guidance, prequalification standards

Data is updated weekly to reflect the latest regulatory changes.

How accurate is the data?

Our data accuracy is maintained through:

• Automated parsing with manual quality review
• Regular updates (weekly for FDA/EMA, as-published for ICH/WHO)
• Version tracking for historical reference
• Citation linking to original source documents

We aim for 99%+ accuracy on structured data fields.

Pricing & Billing

How does pricing work?

CTWiseAPI is billed through AWS Marketplace with monthly subscription tiers:

Tier	Price	API Calls/Month	Best For
Free	$0	1,000	Evaluation
Starter	$99/mo	10,000	Small teams
Pro	$299/mo	50,000	Departments
Enterprise	Custom	Unlimited	Organization-wide

What counts as an API call?

Each HTTP request to any API endpoint counts as one call. This includes:

• Search requests
• Validation requests
• Pattern analysis requests

Failed requests due to client errors (4xx) still count. Rate-limited requests (429) do not count.

What happens if I exceed my limit?

When you reach your monthly limit:

1. API returns 429 Too Many Requests
2. You'll receive an email notification
3. You can upgrade immediately in the dashboard
4. Limits reset on your billing cycle date

Can I upgrade mid-cycle?

Yes! Upgrades take effect immediately. You'll be charged a prorated amount for the remaining days in your billing cycle.

Is there a free trial?

The Free tier provides 1,000 API calls per month indefinitely. For evaluation of paid features, contact sales@ctwise.ai for a 14-day Starter trial.

Technical

What authentication method does the API use?

We use API key authentication via the X-Api-Key header:

X-Api-Key: ctw_YOUR_API_KEY

API keys are created in the dashboard and can be revoked anytime.

Is the API RESTful?

Yes, CTWiseAPI follows REST principles:

• Resources identified by URIs
• Standard HTTP methods (GET, POST)
• JSON request/response bodies
• Stateless interactions

What are the rate limits?

Tier	Requests/Second
Free	2
Starter	10
Pro	50
Enterprise	100

Exceeding rate limits returns 429 Too Many Requests with a Retry-After header.

Is there an SDK?

Yes! Official SDKs are available for:

• Python: pip install ctwise
• JavaScript/TypeScript: npm install @ctwise/sdk

Java, C#, and Go SDKs are coming soon.

How do I handle pagination?

For large result sets, use the max_results and offset parameters:

# Page 1
results = client.search(max_results=100, offset=0)

# Page 2
results = client.search(max_results=100, offset=100)

What's the request timeout?

Default timeout is 60 seconds. Most requests complete in under 3 seconds.

Is the API available globally?

Yes, the API is deployed on AWS with endpoints optimized for:

• North America (us-east-1)
• Europe (eu-west-1) - coming soon
• Asia Pacific (ap-northeast-1) - coming soon

Data & Privacy

Do you store my queries?

We log API requests for:

• Usage metering
• Debugging (retained 30 days)
• Aggregate analytics

Query content is not shared or used for training.

Is data transmitted securely?

Yes:

• All API communication uses TLS 1.2+
• API keys are stored with encryption at rest
• We are SOC 2 Type II compliant

Can I request data deletion?

Yes. Contact support@ctwise.ai to request:

• Account deletion
• Query log deletion
• Usage data export

Integration

Can I use CTWiseAPI with my existing tools?

Yes! CTWiseAPI integrates with:

• CTMS systems: Via REST API or webhooks
• Document management: Export to PDF/Word
• BI tools: JSON export compatible
• CI/CD: SDK support for automation

Do you support webhooks?

Not currently. We're considering webhooks for:

• Regulatory update notifications
• Usage alert notifications

Let us know if this is important for your use case.

Is there a sandbox environment?

The Free tier serves as a sandbox with full API functionality but lower limits. No separate sandbox environment is needed.

Troubleshooting

Why am I getting 401 Unauthorized?

Common causes:

1. Expired API key: Regenerate in dashboard
2. Incorrect header: Must use the X-Api-Key header (capitalized)
3. Key revoked: Check dashboard for status
4. Copy/paste error: Hidden characters in key

Why am I getting 403 Forbidden?

This indicates a tier restriction:

• Requesting features not in your tier
• Accessing authorities (ICH/EMA/WHO) on Free tier

Upgrade to access additional features.

Why are responses slow?

Possible causes:

1. Large result sets: Use max_results to limit
2. Network latency: Check connectivity to us-east-1
3. Complex queries: Simplify search criteria
4. Service degradation: Check status.ctwise.ai

Why am I getting 500 errors?

Server errors are typically transient. Steps:

1. Retry with exponential backoff
2. Check status.ctwise.ai for outages
3. Contact support if persistent

Support

How do I get help?

• Documentation: docs.ctwise.ai
• Email: support@ctwise.ai
• GitHub: Report SDK issues
• Status: status.ctwise.ai

What's the support SLA?

Tier	Response Time
Free	Best effort
Starter	48 hours
Pro	24 hours
Enterprise	4 hours

How do I report a bug?

For SDK bugs:

• Python: github.com/ctwise/python-sdk/issues
• JavaScript: github.com/ctwise/js-sdk/issues

For API bugs:

• Email support@ctwise.ai with request ID