⊹ HVN Portal
▸ ETMF · SITE OPS · MONITORING

Run trials with fewer surprises, on the same calendar.

HVN Portal connects eTMF, site activation, and risk-based monitoring into one regulator-ready system of record. Built with people who've actually run a Phase III.

Request a demo See the platform
01 eTMF

An eTMF that audits clean.

DIA TMF Reference Model out of the box. Quality checks fire at upload — not at lock. Inspection-ready exports in minutes, with a chain of custody your QA team will sign off on.

  • Automatic placeholder generation for required artefacts
  • Signature, version, and protocol-version checks at upload
  • Inspection-mode exports with read-only auditor portal
  • 21 CFR Part 11 and EU Annex 11 compliant audit trail
📄
04.02.01 — Protocol v3.0
Country Pack · DE / IT / PT
✓ filed
📄
02.01.04 — IB v6.1
Sponsor Pack
✓ filed
📄
05.04.06 — IRB approval
SITE-009 · pending committee response
⚠ open
📄
07.01.02 — ICF v2.4
Country Pack · DE
✓ filed
📄
11.03.01 — Monitoring report
SITE-027 · 2026-04-12
✓ filed
02 Site activation

Stop chasing PDFs over email.

Track every regulatory document, contract, and readiness milestone across regions in one queue. The team sees what's next — not what's done already.

  • Pre-built FDA IND, EMA CTA, and MHRA workflows
  • Country-specific document checklists, kept current by our regulatory team
  • Automatic SLA tracking on every cross-team handoff
  • Visibility for sponsor, CRO, and site, without leaking what shouldn't cross
Reg. submission
SITE-009 · Berlin
SITE-021 · Madrid
Contracts
SITE-014 · Lisbon
SITE-024 · Toronto
SITE-031 · Cologne
Active
SITE-027 · Boston
SITE-018 · Dublin
SITE-006 · Amsterdam
SITE-002 · London
03 Risk-based monitoring

The trigger fires before the issue escalates.

Define your protocol's critical-to-quality factors once. The system surfaces drift, anomalies, and overdue actions across sites — quietly, before they become a finding.

  • Risk dashboards backed by your study's CtQ factors, not someone else's
  • Visit reports, follow-ups, and source documents in the same view
  • Centralised statistical monitoring that doesn't require a stats license to read
  • Audit log of every risk decision — defensible by design
↑
SDV variance — SITE-014
+1.8σ from cohort baseline
trigger
●
Visit overdue · SITE-024
Last visit 38 days ago, target 30
trigger
●
AE reporting cadence — normal
SITE-027 · 4 events / 21 patients
✓ ok
●
Withdrawal rate — normal
Cohort B — 4.2%
✓ ok
●
PD trend — flat
Last 30 days · 8 minor
✓ ok
0
Sites under activation
0
Live protocols
0M
eTMF documents
0%
Uptime · last 12 months

One workspace, end to end.

From study start-up through inspection, the same data model travels with you.

▸ STAGE 01

Study start-up

Protocol design, regulatory packaging, vendor selection.

▸ STAGE 02

Site activation

Regulatory submissions, contracts, IRB, readiness.

▸ STAGE 03

Conduct

Monitoring, source verification, deviation tracking.

▸ STAGE 04

Closeout

TMF reconciliation, archiving, final reports.

▸ STAGE 05

Inspection-ready

Auditor portal, evidence packs, defensible exports.

Frequently asked.

The questions our prospective customers ask in the first call. If yours isn't here, write to us.

Most single-study customers go live in 4–8 weeks. Larger CRO portfolios with SOP alignment and validation usually take 12–16 weeks. Every implementation is paired with a clinical-operations consultant from our team.
Yes. The platform is designed and validated against 21 CFR Part 11, EU Annex 11, ICH-GCP E6 (R3), and the relevant ISO standards. Validation packages and the Quality Manual are available under NDA to qualified prospects.
You choose. AWS regions us-east-1, eu-west-1, or eu-central-1 at provisioning. Customer-managed encryption keys are available on the Enterprise tier; keys held in your AWS KMS, every read a logged ciphertext fetch.
Native connectors for Medidata Rave, Veeva Vault, Oracle Argus, and most major CTMS and IRT systems. REST API and SFTP for everything else, with webhooks for downstream automation.
Per study, per module, with portfolio discounts for sponsors and CROs running multiple programs. We don't publish a price list — every program gets a written quote within a week of an initial conversation.

See what a calm trial looks like.

Walk through your protocol with a clinical operations lead from our team. 30 minutes, no slides.

Book a demo