Defensible sponsor oversight,without the reconstruction.
Panoptive captures decision rationale automatically, eliminates hours of manual documentation, and gives you visibility across every trial.
Works with your existing systems
Not a replacement — the intelligence layer that makes your documentation inspection-ready
The Problem
Modern systems. Manual work.
Even with modern clinical systems, sponsors spend hours on work that should take minutes.
The Synthesis Gap
20-page monitoring reports. One text field in your CTMS. Someone still reads, extracts, and writes. That's 2-4 hours gone.
2-4 hrs
per deviation to document
The Rationale Gap
ICH E6(R3) requires documented justification. Free-text fields don't ensure compliance. When inspectors probe, generic rationale fails.
85%
of trials are delayed by inefficient oversight
The Context Gap
Good rationale needs protocol context, prior decisions, and regulatory language - all across different systems. Today, you're the integration layer.
5+
systems to pull context from
How It Works
Decision infrastructure for clinical trials
From monitoring reports to documented decisions. Rationale, citations, and audit trail — generated in seconds.
Input
Monitoring Visit Report — Site 12
Status
Processing...
Detected
3 potential deviations
Sources Analyzed
Protocol, prior visits, ICH-GCP
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
Features
The decision layer above your clinical systems
Panoptive does the work before data entry — reading, drafting, citing. You review and approve.
Reads Full Reports
Not summaries — synthesizes 20+ page monitoring reports for decisions. AI extracts what matters for oversight.
Drafts Rationale
Inspection-ready language, not recaps. Output is regulatory-compliant justification you can approve and file.
Auto-Links Citations
Protocol sections, ICH-GCP clauses, SOPs — all hyperlinked. Every decision backed by proper references.
Cross-Trial Visibility
See oversight activity across all your trials in one place. Spot patterns, track open items, and know where you stand before anyone asks.
Compliance
Built for regulatory compliance
Every decision record meets the documentation standards inspectors expect.
Risk-Based Oversight
Documented justification for proportionate oversight decisions — the core requirement of modern GCP.
- Proportionate oversight rationale
- Risk-based decision documentation
- Quality management evidence
Sponsor Responsibility
Demonstrate adequate assessment and oversight of investigations with retrievable decision records.
- Oversight decision audit trail
- Investigator assessment records
- Regulatory submission ready
Device Trials
Decision traceability for notified body audits with complete documentation chains.
- Notified body audit ready
- Decision traceability
- MDR compliance documentation
Pricing
Choose the right plan for your team
All plans include audit-ready decision records, rationale generation, and citation linking.
Pilot
Prove the value
- 1 active trial
- Decision capture
- Rationale generation
- Citation linking
- Email support
Growth
Scale across trials
- Up to 10 trials
- Everything in Pilot
- Cross-trial dashboard
- CTMS integrations
- Priority support
Enterprise
Full portfolio
- Unlimited trials
- Everything in Growth
- Custom integrations
- SSO / SAML
- Dedicated CSM
- Custom workflows
Not sure which plan? Book a call and we'll help you figure it out. Book a call
Stop writing rationale manually.
See how Panoptive makes every oversight decision audit-ready. Book a demo — we'll show you live.