Helix Browser
For regulated life sciences

An intelligence terminal for regulated life sciences.

Helix Browser gives pharma and biotech teams a governed AI workspace for clinical, regulatory, safety, and R&D workflows — with private agents, human approval gates, evidence trails, and enterprise controls.

No adsNo trackingNo telemetryPrivate deploymentHuman-in-the-loopFull audit trails
helix://workspaces/clinical-ops/STUDY-PR-204/protocol-v3.2Private tenant
ProtocolSTUDY-PR-204v3.2 — amendment review

Phase 2b — Adaptive dose escalation, oncology

PROT-204EUCT 2025-002311-44v3.2 · 14 Mar 2026
Inclusion criteria drift detected
Protocol §4.1 vs v3.1

ECOG threshold widened from 0–1 to 0–2 without matching safety run-in update.

Matching FDA guidance
FDA Oncology — Dose Optimization, 2023

Recommends randomized parallel dose evaluation prior to expansion cohort.

Site readiness signal
CTMS · 18 active sites

All sites have re-consented per amendment v3.1; v3.2 re-consent not yet issued.

Audit trail· STUDY-PR-204
10:42:18j.okaforagent.runcompare.protocol_v3.1→v3.2approved
10:42:55agent.clinevidence.citefda.dose_optim.2023 §3.2verified
10:43:11agent.clindraft.createha_response.v0.4pending review
10:43:40m.lindqvistapproval.requestdirector.reviewqueued
Telemetry
94%
faster evidence triage
Telemetry
12
systems unified
Telemetry
100%
action traceability
Telemetry
0
data used for training
Telemetry
GxP
ready controls

Example pilot metrics · configurable per deployment

The shift

From fragmented portals to governed agents.

Fragmented evidence

Teams jump between literature, trial registries, regulatory portals, EDC, CTMS, eTMF, ELN, LIMS, safety databases, and shared drives.

Opaque AI

Generic copilots summarize content without provenance, controlled vocabularies, approval gates, or validated audit trails.

Manual compliance burden

Every clinical, regulatory, safety, and quality workflow still requires screenshots, manual notes, repeated checks, and disconnected signoffs.

TabsAgents
SearchEvidence graph
DraftsReviewed outputs
ScreenshotsAudit packets
Generic AIValidated workflows
Uncontrolled browsingGoverned intelligence terminal
Architecture

Four layers. One governed pipeline.

Layer 01
Intent layer

Declarative pharma workflows. Users ask for outcomes like “compare this protocol against FDA guidance,” “monitor safety literature,” or “draft a response to an agency question.”

Layer 02
Agent runtime

Private, role-scoped agents operate in sandboxed workspaces with approved tools, approved sources, SOP-aware behavior, and human approval gates.

Layer 03
Evidence mesh

Every output links back to source documents, citations, datasets, protocol sections, safety cases, regulatory guidance, and version history.

Layer 04
Compliance record

Every action becomes a reviewable audit trail with user, timestamp, input, model, source, decision, approval, and exportable evidence packet.

Intent
Agent action
Evidence check
Human approval
Audit record
Export
Agent fleet

Purpose-built agents for pharma and biotech.

Private · review-gated · auditable
Clinical protocol agent
  • Compare protocol versions
  • Flag inclusion/exclusion drift
  • Identify operational risks
  • Generate review packets
Private · review-gated · auditable
Regulatory intelligence agent
  • Monitor global agency updates
  • Summarize guidance changes
  • Map impact to active programs
  • Draft response outlines
Private · review-gated · auditable
Pharmacovigilance agent
  • Triage safety literature
  • Detect emerging signals
  • Prepare case narratives
  • Route for medical review
Private · review-gated · auditable
Medical affairs agent
  • Generate evidence summaries
  • Compare publications
  • Prepare MSL briefing packets
  • Maintain citation provenance
Private · review-gated · auditable
R&D discovery agent
  • Review targets and pathways
  • Summarize omics findings
  • Compare assay results
  • Track competitor programs
Private · review-gated · auditable
Quality & validation agent
  • Review SOP adherence
  • Prepare inspection evidence
  • Monitor CAPA documentation
  • Build audit-ready packets
Compliance

Compliance-ready by design.

Helix Browser is built for regulated environments. Designed to support and configurable for the frameworks your teams already operate under.

21 CFR Part 11GxPGCPGMPGDPRHIPAA
Electronic records and signatures support
Human approval gates
Tamper-evident audit logs
Data lineage and source provenance
Role-based access control
SOP-aware workflow templates
Model and prompt version tracking
Exportable validation packets
Configurable retention policies
Inspection-ready evidence bundles

Disclaimer — Compliance posture depends on deployment configuration, validation, governance, and customer SOPs.

Security

Private intelligence for sensitive science.

Deployment
  • Private cloud or VPC deployment
  • Full tenant isolation
  • Data residency options
Identity & access
  • SSO / SAML / SCIM
  • RBAC and ABAC permissions
  • Role-scoped agent sessions
Keys & encryption
  • Customer-managed keys
  • HSM / KMS integration
  • Encrypted at rest and in transit
Data governance
  • Zero data retention mode
  • No customer data used for model training
  • Private model routing
Observability
  • SIEM export
  • SOC 2 readiness controls
  • Real-time access logs
Privacy
  • DLP and PHI/PII detection
  • Redaction before model execution
  • Configurable masking
Integrations

Built around the systems pharma already uses.

Helix Browser does not replace validated systems of record. It becomes the governed intelligence layer across them.

Veeva Vault
eTMF
CTMS
EDC
LIMS
ELN
Safety database
SharePoint
Teams
PubMed
ClinicalTrials.gov
FDA
EMA
Internal data lake
Snowflake
Databricks
ServiceNow
Jira
Product surface

The browser disappears. The workflow remains.

Command palette⌘ K
Ask Helix…
Agent permissionApproval required
Requested actiondraft.ha_response.v0.4
Data sourcesFDA · EMA · Internal submissions
Systems touchedVeeva Vault · eTMF
Risk levelModerate
Required approvalDirector, Regulatory
Evidence drawer
FDA Oncology — Dose Optimization
FDA · guidance · 2023.05conf 0.94
Last reviewed · 12 Mar 2026
Protocol STUDY-PR-204 v3.2
Veeva Vault · eTMF · v3.2conf 1.00
Last reviewed · 12 Mar 2026
Lancet Oncol — adaptive escalation
PubMed · PMID 38219442 · 2024conf 0.81
Last reviewed · 12 Mar 2026
Audit trail
UserAgentActionTimestampModelApproval
j.okaforagent.clincompare.protocol2026-03-14 10:42:18helix-1.4-r2approved
agent.regagent.regmonitor.guidance2026-03-14 10:44:02helix-1.4-r2auto
m.lindqvistagent.clindraft.create2026-03-14 10:45:11helix-1.4-r2pending
agent.pvagent.pvsignal.detect2026-03-14 10:46:30helix-1.4-r2review
a.morales—export.packet2026-03-14 10:48:55—completed
Enterprise

For global pharma operating at regulated scale.

Dedicated deployment

Private tenant, VPC, custom data residency, enterprise key management.

Validated workflows

Configurable workflow templates aligned to internal SOPs and validation requirements.

Named support

Enterprise onboarding, solution architects, security review, deployment support, and success management.

Governance console

Centralized policy controls for agents, models, prompts, tools, data sources, and approvals.

Use cases

One terminal. Every regulated workflow.

Workflows
  • Guidance impact assessment
  • Agency response drafting
  • Label change comparison
Data sources
  • FDA guidance
  • EMA guidance
  • Internal submission archive
Sample agent output

Drafted response outline with 14 cited sources and 3 sections requiring regulatory review.

Audit snippet

Action paused pending director approval.

The web began as documents.

Pharma made it evidence.

Then systems of record.

Then portals.

Then dashboards.

Now it becomes governed execution.

Where scientific work is traceable.

Where agents ask before they act.

Where evidence stays attached.

Where every decision can be reviewed.

Where regulated teams move faster without losing control.

Not a browser.

An intelligence terminal for life sciences.

Pilot program

Pilot Helix Browser with your enterprise team.

Designed for pharma and biotech organizations that need private AI, governed workflows, and audit-ready execution across regulated knowledge work.