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Frequently Asked Questions

Common questions about CTWiseAPI.

General​

What is CTWiseAPI?​

CTWiseAPI provides programmatic access to regulatory intelligence for clinical trial protocol development. It helps pharmaceutical and biotech companies:

  • Find regulatory requirements from FDA, ICH, EMA, and WHO
  • Analyze historical amendment patterns
  • Validate protocols against current guidance
  • Prevent costly protocol amendments

What data sources does CTWiseAPI use?​

We aggregate and structure guidance from:

  • FDA: Guidance documents, Federal Register notices, CDER/CBER publications
  • ICH: Harmonized guidelines (E6, E8, E9, etc.)
  • 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  • Version tracking for historical reference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:

TierPriceAPI Calls/MonthBest For
Free$01,000Evaluation
Starter$99/mo10,000Small teams
Pro$299/mo50,000Departments
EnterpriseCustomUnlimitedOrganization-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 Bearer token authentication with API keys:

Authorization: Bearer ctwise_sk_live_xxx

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?​

TierRequests/Second
Free2
Starter10
Pro50
Enterprise100

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 key format: Must include Bearer prefix
  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?​

TierResponse Time
FreeBest effort
Starter48 hours
Pro24 hours
Enterprise4 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: