Solutions · Regulated industries
The audited AI platform
for life sciences.
Sponsors, CROs, contract manufacturers, diagnostics labs, and digital therapeutics companies. AI for protocol summarization, monitoring reports, regulatory submissions, and site correspondence — with an audit chain built for FDA 21 CFR Part 11, EMA Annex 11, and GxP recordkeeping expectations.
Built-in compliance
Every action logged. Every log verifiable. By anyone.
- Audit chain captures Part 11 attribution data — who, what, when, with what intent — and the export is structured to support inspection responses without redaction or reformatting.
- HASP's PHI scanning extends to clinical-trial subject identifiers, investigator-name pairs, and case-report-form data — configurable per study or per protocol.
- DPA, sub-processor list, and data-residency commitments are available pre-signature; QA teams can review controls before the contract is in front of legal.
What teams use HASP for
The workflows that brought you here.
Protocol and amendment summarization
Long-form clinical protocols and protocol amendments summarized into investigator-facing briefs and site-feasibility memos. Every summary version is in the audit chain with timestamp and signing identity — Part 11 attribution captured, not assumed.
Monitoring reports and site-correspondence drafting
Clinical research associates draft monitoring visit reports, site correspondence, and protocol-deviation memos from raw visit notes and source-data verification findings. The chain captures the source notes, the AI's draft, and the monitor's edits — exactly the lineage FDA Form 483 inspections request.
Regulatory submission narrative drafting
IND, NDA, BLA, and CTA submission narrative sections drafted from study results and prior submissions. Every section is signed, every revision is traceable, and the export is structured to match what regulatory affairs teams hand to FDA or EMA.
GxP-aware document and SOP review
Standard operating procedures, batch records, and validation documents reviewed and summarized for departmental training and CAPA workflows. Hash-chained revision history makes it clear which content predates AI involvement and which doesn't.
Manufacturing and quality investigation summaries
Deviation investigations, OOS results, and CAPA narratives drafted from raw lab data and analyst notes. The same audit-export your auditors verify independently is also the document trail your CAPA system relies on.
The HASP platform, on this surface
Product surfaces that matter most for life sciences.
Product
Chat & documents
A HIPAA-ready chat interface and document analysis tool for your whole team. Ask questions, get summaries, upload files — all with PHI scanning built in and every action on your audit trail.
View Chat & documents →Product
Audit & Trust
A tamper-evident record of every action across every surface — signed, chained, and independently verifiable. The thing procurement teams stop scrolling for.
View Audit & Trust →Product
API
Add HIPAA-compliant AI to your own software. Drop in your existing AI SDK code, get PHI controls and a full audit trail enforced at the gateway — your integration stays clean.
View API →See it end-to-end
Workflows that map to life sciences.
Try it before you commit to anything.
Start a Free Evaluation and use every feature — AI chat, document analysis, the API, internal app builder — on non-patient data. When your organization is ready to work with real patient records, sign the BAA in-app. No procurement back-and-forth, no waiting.