Clinical Trials & FDA Pipeline Intelligence Scraper

Unified clinical-trial + FDA intelligence in one actor. Search ClinicalTrials.gov, fetch FDA drug approvals, 510(k) and PMA device clearances, adverse events, recalls, and active drug shortages — and roll them all up into a single sponsor-pipeline view that no incumbent ships.

Built on two official, public, no-auth APIs: ClinicalTrials.gov v2 and OpenFDA. Every output row carries a verifyUrl that links to the canonical public page so you can audit the data with one click.

What does this actor do?

It pulls structured biomedical regulatory data and unifies it into one normalized output shape. Ten modes cover the full surface:

Mode	Records returned	Buyer use case
trials	NCT records with phase, status, conditions, comparators, locations, primary endpoints	Search trials by indication / sponsor / phase / status
trial_details	Full study record incl. eligibility criteria, secondary endpoints, sponsors/collaborators	Deep dives on specific NCTs
drug_approvals	NDA / ANDA / BLA submissions with all status changes, products, NDCs	Approval timeline + commercial reality
device_clearances	510(k) + PMA records with decision date, decision, product code	Med-device pipeline tracking
adverse_events	PII-stripped FAERS reports — reactions, seriousness, demographics	Pharmacovigilance signals
recalls	FDA enforcement (Class I / II / III) — reason, distribution, status	Compliance & QA monitoring
shortages	Active or resolved drug shortages with availability + reason	Hospital / pharmacy planning
pipeline	One row per sponsor merging trials + approvals + clearances + recalls + shortages + next catalyst	Alt-data hedge fund, biotech VC, pharma BD
monitor	Incremental change events vs. prior runs — new trials, status changes, new approvals, recalls	Scheduled daily / weekly diffs
ai_summary	Gemini 2.5 Flash structured summary — TL;DR, risk flags, milestone class, outcome prior	Premium analyst layer

Free trial: the first 10 chargeable events of every run are free. Pay only on the 11th event onward.

Why use this actor?

• Biotech VCs / hedge funds — build a catalyst calendar from pipeline.nextCatalystDate and upcomingMilestones[]. Every trial readout, PDUFA-class submission, and 510(k) decision is normalized and ticker-tagged when the sponsor maps to an SEC filer.
• Pharma BD / corp dev — find Phase 2 oncology assets at small biotechs, see their FDA submission history, then pivot to drug labels for MOA inference. Sponsor resolver bridges to SEC tickers when public.
• CROs / clinical operations — query for RECRUITING Phase 3 trials in a target country, get full locations[] with city + facility + status.
• Insurance underwriters / pharmacovigilance teams — pull adverse-event trends per drug with serious=true breakdowns. PII is stripped (no names, no contact info, no narrative free text) before the row is written.
• Hospital pharmacy / supply chain — shortages mode lists every currently-active FDA drug shortage with availability, generic name, and affected NDCs. Schedule daily and pipe alerts.
• Compliance / QA — recalls mode returns Class I / II / III enforcement actions with classification, recall reason, and distribution pattern. Combine with monitor for new-recall alerts.
• AI / LLM training — every record has a stable PK (NCT, ANDA, k_number, recall_number) and a public verifyUrl. Perfect for grounded biomedical knowledge graphs.
• Public-health researchers — trial geography by condition, sponsor class breakdowns, no API key required.

How to use this actor

1. Pick a mode — see the table above. The most common starting points are trials (search) and pipeline (sponsor rollup).
2. Set your filters — conditions, phases, sponsor identifiers (ticker / name / domain / CIK), date range, etc.
3. Run it — first 10 chargeable events per run are free; you only pay on the 11th and beyond. Set maxItems: -1 for unlimited bulk extraction (the actor uses nextPageToken and search_after pagination automatically).
4. Verify any record — click the verifyUrl field on any output row to land on the source's canonical page (clinicaltrials.gov, accessdata.fda.gov, etc.).
5. Export as JSON / CSV / Excel from the dataset, or hit the dataset API directly to chain into a downstream workflow.

Input

Search Phase 3 lung-cancer trials currently recruiting

{
    "mode": "trials",
    "conditions": ["non-small cell lung cancer"],
    "phases": ["PHASE3"],
    "statuses": ["RECRUITING"],
    "maxItems": 100
}

Full trial details by NCT ID

{
    "mode": "trial_details",
    "nctIds": ["NCT04368728", "NCT05636956"],
    "maxItems": 10
}

Pfizer's recent FDA drug approvals

{
    "mode": "drug_approvals",
    "sponsorIdentifiers": ["PFE"],
    "dateFrom": "2024-01-01",
    "maxItems": 50
}

Medtronic's 510(k) cardiac-monitor clearances

{
    "mode": "device_clearances",
    "applicantName": "Medtronic",
    "productCode": "DXN",
    "devicePathways": ["510k"],
    "maxItems": 25
}

Serious Ozempic adverse events

{
    "mode": "adverse_events",
    "drugName": "Ozempic",
    "seriousOnly": true,
    "maxItems": 200
}

Class I drug recalls in last 90 days

{
    "mode": "recalls",
    "recallClassifications": ["Class I"],
    "recallDomains": ["drug"],
    "dateFrom": "2026-02-01",
    "maxItems": 50
}

Active drug shortages

{
    "mode": "shortages",
    "shortageStatus": "currently_in_shortage",
    "maxItems": 100
}

Sponsor pipeline rollup (the killer mode)

{
    "mode": "pipeline",
    "sponsorIdentifiers": ["MRNA", "PFE", "LLY"],
    "maxItemsPerSource": 1000
}

Monitor for changes (run on a schedule)

{
    "mode": "monitor",
    "monitorTargets": ["NCT04368728", "MRNA", "PFE"],
    "maxItems": 100
}

AI-powered structured summary

{
    "mode": "ai_summary",
    "nctIds": ["NCT04368728"],
    "enableAiSummary": true
}

Output

Trial record (sample)

{
    "type": "trial",
    "id": "NCT06840782",
    "nctId": "NCT06840782",
    "briefTitle": "First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic NSCLC",
    "conditions": ["Oligometastatic Non-small Cell Lung Cancer (NSCLC)"],
    "interventions": [
        { "type": "EXPERIMENTAL", "name": "Radiation: Radical local treatment", "description": "..." }
    ],
    "comparators": [
        { "type": "ACTIVE_COMPARATOR", "name": "Drug: SoC-based immunotherapy", "description": "..." }
    ],
    "phase": "PHASE3",
    "status": "RECRUITING",
    "enrollmentTarget": 124,
    "actualEnrollment": 124,
    "studyDesign": {
        "allocation": "RANDOMIZED",
        "interventionModel": "PARALLEL",
        "masking": "NONE",
        "primaryPurpose": "TREATMENT"
    },
    "primaryEndpoints": [
        {
            "measure": "Overall Survival (OS)",
            "timeFrame": "From randomization up to two years",
            "description": "Time from randomization to documented death from any cause"
        }
    ],
    "sponsorClass": "OTHER",
    "locations": [
        { "facility": "Gustave Roussy", "city": "Villejuif", "country": "France", "status": "RECRUITING" }
    ],
    "countries": ["France"],
    "primaryCompletionDate": "2030-02",
    "hasResults": false,
    "lastUpdateSubmitDate": "2025-09-12",
    "verifyUrl": "https://clinicaltrials.gov/study/NCT06840782",
    "scrapedAt": "2026-05-04T11:34:45.860Z"
}

Pipeline record (sample, Moderna abridged)

{
    "type": "pipeline",
    "id": "0001682852",
    "ticker": "MRNA",
    "cik": "0001682852",
    "trialCountTotal": 111,
    "trialCountByPhase": { "PHASE1": 48, "PHASE2": 22, "PHASE3": 18, "PHASE4": 4 },
    "trialCountByStatus": { "COMPLETED": 71, "RECRUITING": 12, "ACTIVE_NOT_RECRUITING": 19 },
    "trialCountActiveRecruiting": 31,
    "drugApprovalCount": 1,
    "topConditions": [
        { "condition": "SARS-CoV-2", "trialCount": 31 },
        { "condition": "Influenza", "trialCount": 13 },
        { "condition": "Respiratory Syncytial Virus", "trialCount": 11 }
    ],
    "upcomingMilestones": [
        { "nctId": "NCT07089706", "milestone": "primary_completion", "date": "2026-08", "daysUntil": 92 }
    ],
    "nextCatalystDate": "2026-08",
    "nextCatalystType": "primary_completion",
    "nextCatalystId": "NCT07089706",
    "regulatorySignal": 0,
    "verifyUrl": "https://clinicaltrials.gov/search?spons=Moderna%20Inc"
}

Verify any record

Record type	URL pattern
Trial	https://clinicaltrials.gov/study/<NCT_ID>
Drug approval	https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=<#>
510(k) clearance	https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=<K_NUMBER>
PMA approval	https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=<P_NUMBER>
Recall	https://www.accessdata.fda.gov/scripts/ires/index.cfm?Recall_Number=<#>

How much does it cost?

Pay-per-event pricing (the first 10 events of any run are free):

Event	Price	What you get
trial-fetched	$0.0003	One CT.gov trial record
trial-details-fetched	$0.0006	Full trial detail (eligibility + endpoints + results)
drug-approval-fetched	$0.0004	One FDA drug application with all submissions
device-clearance-fetched	$0.0004	One 510(k) or PMA clearance
adverse-event-fetched	$0.00015	One PII-stripped FAERS report
recall-fetched	$0.0004	One FDA enforcement action
shortage-fetched	$0.0004	One drug-shortage record
pipeline-aggregated	$0.02	One sponsor pipeline rollup (synthesizes 5+ source queries)
change-detected	$0.0003	One change event in monitor mode
ai-summary-generated	$0.05	One Gemini 2.5 Flash structured summary

Typical run costs

• 100-trial NSCLC search: ~$0.027
• Pfizer drug approval scan (250 records): ~$0.10
• Daily class-I-recall watch (5 records / day): ~$0.002 / day
• Weekly pipeline scan, top 10 biotech sponsors: ~$0.20 / week
• Sponsor pipeline + AI summary (1 sponsor): ~$0.07

Compare to enterprise alternatives:

• Citeline / Datamonitor: $10K+/yr/seat
• Phesi: $5K+/yr/seat
• BioPharmaCatalyst: $99/mo
• GlobalData Pharma: enterprise pricing

Tips & advanced options

• Bulk extraction — set maxItems: -1 and the actor will use search_after (Link header rel="next") on OpenFDA and nextPageToken on CT.gov to scroll through the entire dataset. There is no built-in cap.
• OpenFDA API key — anonymous tier is 1,000 req/day per IP. For bulk users, set the optional openFdaApiKey input (free at https://open.fda.gov/apis/authentication, 120K req/day).
• Sponsor resolution — every output row has sponsor.matchConfidence ∈ {exact, alias, fuzzy, raw}. exact = SEC ticker bridge, alias = hand-curated biopharma index (Wyeth → Pfizer, Genentech → Roche, etc.), fuzzy = token-set match, raw = passthrough. Audit ambiguous matches by checking the field.
• Monitor mode — run on a schedule (Apify integrations → Schedule daily). The first run seeds fingerprints and emits 0 changes; subsequent runs emit only new or changed rows.
• Pipeline mode runtime — for busy sponsors (Pfizer ≈ 600+ trials, ≈ 200 approvals), the parallel fan-out takes 30–60 seconds. Tighten with maxItemsPerSource: 500 to reduce wall time.
• Combining mode + AI — set enableAiSummary: true in pipeline mode to attach a Gemini structured summary to every sponsor row. Adds $0.05 per sponsor.
• Out of scope (v1) — EU CTIS, WHO ICTRP, Health Canada, FDA orphan / breakthrough / fast-track designations. These are scoped for a future v2.

Legal disclaimer

This actor consumes only public data from official US-government APIs (ClinicalTrials.gov v2, OpenFDA). Both APIs are open, free, and explicitly distributed for re-use under federal open-data policy. The actor does not bypass authentication, does not scrape content from third-party sites, and does not violate the terms of service of either source.

Adverse-event records are PII-stripped at emit time (utils/piiStrip.ts): emails, phone numbers, and SSN-shaped values are redacted. Patient identifiers are not present in the source data.

This data is provided for research, analytical, and informational purposes only. Do not use for medical decisions. OpenFDA's own disclaimer states: "Do not rely on openFDA to make decisions regarding medical care."

FAQ

Q: My sponsor returned matchConfidence: "raw". Why? A: Raw passthrough means the sponsor name didn't match an SEC ticker, didn't match a hand-curated biopharma alias, and didn't fuzzy-match within threshold. The actor still ran the query as-is. Either submit an SEC ticker / canonical name, or add the sponsor to your custom alias list (open a feature request).

Q: My pipeline mode showed drugApprovalCount: 0 for a company that obviously has approvals. A: OpenFDA tracks legal entities by sponsor_name. Subsidiaries (e.g. ModernaTX, Inc.) may file under names that don't match the parent (Moderna Inc). Try passing the subsidiary string directly: sponsorIdentifiers: ["ModernaTX, Inc."]. Future v2 will widen the alias index.

Q: How fresh is the data? A: ClinicalTrials.gov v2 reflects the current live database. OpenFDA datasets update on different cadences — drug approvals weekly, adverse events quarterly, recalls daily, shortages weekly. Each row's scrapedAt reflects when this actor fetched it; OpenFDA's last-update date is in meta.last_updated of the underlying API.

Q: Can I get EU trials? A: Not in v1. EU CTIS uses an undocumented POST search endpoint and EUDRA-CT requires HTML scraping. Add as a feature request.

Q: Does the AI summary hallucinate? A: Gemini 2.5 Flash with thinkingBudget: 0 and temperature: 0.2 is constrained to JSON output and only sees the structured record (no external context). It does not invent NCT IDs or sponsor names. Outcome priors are calibrated to BIO/Biomedtracker industry base rates (Phase 1→2 ~63%, Phase 2→3 ~31%, Phase 3→NDA ~58%, NDA→approval ~85%).

Q: How do I report a bug? A: Open an issue on the Apify actor page or reach out via the developer's email (omar.eldeeb@remotegrowthpartners.com).