The continuous oversight engine for clinical trials.

Turn monitoring reports and EDC data into structured findings, documented decisions, and a continuously audit-ready oversight record.

What did we know, what did we do, and can we defend it?

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See it in action

01 — Study oversight, evaluated continuously

02 — Every event and decision, traceable to source

home / studies / fleming WORKSPACE Overview Review Queue 24 Cases Signals Systemic Review LIBRARY Documents Data Imports DECISIONS Decisions Obligations COMPLIANCE Audit Simulation Audit Trail AF Alexander Fleming Panoptive Bio Studies / FLEMING… Search signals, decisions… Ask Panoptive First Look at Evolving Microbial Innovation with Novel Genomics FLEM-0042 Helix Therapeutics · 25 signals last updated 4 days ago Oversight health · 59/100 — Needs Attention 6 critical signals · 24 findings pending review · 13 issues without documented resolution Open review panel 59 / 100 Needs Attention Early phase · day 134 Confidence: Medium Current state 6 critical signals open 24 findings pending review Summary Top risks Score trend last 30 days Jun 5 Jun 18 Jun 28 Coverage 92 Decision completeness 35 Execution quality 100 Timeliness 78 Risk resolution 22 Inspection readiness 61 Updated continuously from monitoring reports & EDC
home / cases / dose-management-site-014 WORKSPACE Overview Review Queue 24 Cases Signals Systemic Review LIBRARY Documents Data Imports DECISIONS Decisions Obligations COMPLIANCE Audit Simulation Audit Trail AF Alexander Fleming Panoptive Bio Studies / Cases / Dose-management workflow… Close case Reopened Dose-management workflow — Site 014 CASE-92a6c6-5014-DM-002 · Site scope · Site 014 · Dose management · Opened Jun 10 2026 CRITICAL RULE-BOUND Detected recurrence after CAPA closure New evidence raised after the corrective action was closed reopened this case. Case timeline is preserved below. Draft Decision v2 Case timeline 13 events Jun 3 · 2026 · Cross-source Subject 014-004 dosed at 20 mg after K+ 5.0 withhold breach Source document → Jun 6 · 2026 Subject 014-004 restarted at 10 mg above restart threshold Source document → Jun 10 · 2026 · CAPA CAPA closed — dose-management controls verified at Site 014 Source document → Jul 3 · 2026 · Recurrence · post-closure Recurrence — Subject 014-017 dosed at 20 mg, K+ 5.1 breach Source document → CASE RECORD Case code 92a6c6-5014-DM-002 Scope Site Theme Dose management Severity Critical Status Reopened · Jul 3 Binding Rule-bound LINKED SIGNALS (8) CRITICAL CRITICAL MAJOR Decision trail preserved · defensible at inspection

Works with your existing systems

Veeva
Medidata
Oracle
+ more

& custom setups

Not a replacement — the intelligence layer that makes your documentation inspection-ready

The Problem

By the time of inspection,audit trails are reconstructedunder pressure.

  • Oversight data is fragmented across monitoring reports, EDC systems, trackers, and email threads.
  • Findings are buried in multi-page reports, and systemic issues across sites go undetected until they've already compounded — leading to delays, retraining, and protocol changes.
  • When inspection begins, teams are forced to reconstruct the decision trail — exposing gaps when it matters most.

→Issues surface under inspection — not during the study.

Reports
EDC
Trackers
Email
Decision
trailReconstructed

Reconstructed under pressure

This is the gap Panoptive closes.

The Panoptive Loop

From finding to decision to defensible audit trail — continuous, human-first.

1

Surface Findings

Findings extracted from reports and EDC data

2

Structure Decisions

Sponsor decisions with evidence and rationale

3

Continuous Audit Readiness

Inspection-ready oversight record

Decision infrastructure for clinical trials

Turning scattered data signals into documented decisions. Rationale, citations, and audit trail — generated in seconds.

Site 12 Monthly Report73 pages

Input

Monitoring Visit Report — Site 12

Status

Processing...

Detected

3 potential deviations

Sources Analyzed

Protocol, prior visits, ICH-GCP

Decision RecordGenerated in 47s

Classification

Minor protocol deviation — documentation

Rationale

Informed consent obtained but signature page misfiled. No impact on subject safety or data integrity per ICH E6(R3) 3.9.3.

Citations

Protocol v2.1 §8.3, ICH E6(R3) 3.9.3, SOP-CM-042

Action Required

Site to refile within 5 business days

Analyzes unstructured data

Flags safety and quality findings across trial monitoring data.

Drafts inspection-ready rationale

Regulatory-compliant justification you can review, approve, and file.

Auto-links citations

Protocol sections, ICH-GCP clauses, SOPs — all hyperlinked automatically.

Cross-trial visibility

See decisions and open items across all your trials in one place.

ReconstructionContinuous record

Findings buried in multi-page reports
Findings surfaced across reports and data
Patterns missed across sites
Cross-site patterns identified early
Decisions tracked in spreadsheets and email
Structured decisions with evidence and rationale
Audit trail reconstructed under pressure
Continuous, audit-ready oversight record

When signals, decisions, and actions are fragmented, issues get missed — and only surface under inspection.

Panoptive closes that gap — surfacing findings early and turning every decision into a documented, traceable, defensible record.

Return on Investment

Faster decisions. Lower risk.
Always inspection-ready.

30–50%
less CTM / QA review time

Accelerate Decisions

≈1–2 hours saved per monitoring report — from intake to decision.

Earlier
issue detection

Reduce Risk

Catch issues early and avoid retraining cycles, protocol amendments, and last-minute remediation.

Continuous
audit readiness

Ensure Audit Readiness

Replace weeks of audit preparation with a continuous, inspection-ready oversight record.

What teams are saying

Built for the people accountable for oversight

Visibility across sites

“We were stitching together oversight from reports, trackers, and emails. Now we can clearly see findings, decisions, and follow-up in one place.”

Head of Clinical Operations

Growth-stage sponsor

Inspection readiness

“This is the first time we can see our oversight the way an inspector would — and know exactly where the gaps are before they do.”

Head of Clinical Quality

Mid-stage medical device company

Time & cost savings

“This turns hours of review and audit prep into a structured package — findings, rationale, evidence, and next actions.”

Clinical Quality / Affairs Leader

Emerging biotech sponsor

Pilot

Run a pilot on your study — and see how your oversight holds up in an inspection.

Evaluate your oversight on real study data — before an inspector does.

See ROI in weeks
Test on a sample of study data
No integration required

What you get

Inspection-readiness oversight package built from your real monitoring data — including findings, decisions, and inspection gaps and how to fix them.

→ Typical output comparable to a full mock audit engagement.

quick setup · fixed scope · pilot pricing

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SOC 2 Type II
21 CFR Part 11 and HIPAA-aligned
Encrypted at rest and in transit with strict data isolation

See how your oversight holds up in an inspection.

Run a focused pilot on your study to surface gaps, structure decisions, and generate an inspection-ready record — before an auditor does.

Start a pilotOr see a live walkthrough