AI-native site operating layer
LeapYear
Afore CapitalActivate your sites faster.
Move sites from selected to ready-to-enroll. Collect essential documents, catch what blocks activation, and track every site on one board. PHI-free.
A context-aware agent reads your activation program and proposes next steps. You approve every action.
North Valley Research · 1 open blocker
GL-450 Small Cell Lung Cancer · 8 of 12 sites at FPI risk
- 8
- FPI risk
- 282
- pending
- 5
- findings
02 · Turnaround
~7.5 days saved vs typical chase
03 · Expiry radar
Sofia Brandt, MD
Gulf Coast Oncology · expires Jul 3
North Valley Laboratory
North Valley Research · expires Jul 7
04 · Agent
What should we clear before IRB at North Valley?
- Issue upload link · Site 022 · delegation log
- Review blocker · North Valley · PI license
Proposes from program context · you approve
Institution names describe prior team experience only. No endorsement or affiliation implied. Prior experience in clinical research operations, regulatory evidence, and multi-site study execution.
Uploaded is not activation-ready.
Most activation teams can tell you a document was submitted. Fewer can tell you whether it's complete, current, consistent across forms, and cleared for the next gate.
That invisible gap is where activation slips, and where FPI risk compounds site by site. GreenLight makes readiness visible at every step.
- Uploaded≠Document submitted
- Accepted≠Required fields present
- Current≠Latest approved version
- Consistent≠Matches across documents
- Activation-readyclearedCleared for first patient in
Five gates. One operating layer.
Every site moves through the same activation spine. GreenLight tracks where each site sits, what each gate needs, and which open findings freeze progress until a human accepts or dismisses them.
- Gate 01
Collection
Issue upload links; track what's received, overdue, and outstanding per requirement.
- Gate 02current
IRB
Assemble packets; catch ICF/protocol version drift and continuing-review expiry.
- Gate 03
Training
GCP and study-specific training verified before SIV.
- Gate 04
SIV
Site initiation readiness: delegation logs, pharmacy, equipment, signatures.
- Gate 05
Activate
Evidence-backed clearance to enroll first patient.
Findings run across every gate. A blocking discrepancy (name mismatch, expired license, wrong ICF version) holds the site until your team dispositions it. No auto-resolve. Full audit trail.
Plan once. Collect at scale. Run the activation queue.
One pipeline from protocol to activation-ready, with a live operating layer over every site for sponsors and CROs.
Plan the requirement set
GreenLight reads your protocol and resolves a curated regulatory library (FDA 1572, PI CV and license, IRB approvals, GCP training, contracts, delegation logs) into the exact checklist for each site, each IRB, and each role. No template hunting. No missed forms.
Collect and validate
Site staff upload through expiring, tokenized links. No account, no portal training. AI extraction plus deterministic rules check identity across forms, version alignment, credential expiry, and signatures. Every discrepancy becomes a finding with a document, page, and field citation.
Run the activation queue
See every site on one board: gate status, days-to-ready, open blockers, and projected activation cut vs. baseline. A context-aware agent proposes next steps from your program state. You approve every action.
Discrepancies surfaced at upload, not at IRB or sponsor QC.
GreenLight catches the issues that actually block activation. Each finding carries evidence, severity, and confidence. Your CTAs review exceptions; the system never auto-clears a blocker.
- Blocking
PI identity mismatch across 1572, CV, and license
evidence ·1572 § 1 vs CV header · p. 1
- Blocking
Protocol version inconsistency across signed documents
evidence ·Site signature dated against v3 · current v4
- Blocking
Credential expires before site target-ready date
evidence ·PI license expires 2026-08-12 · target 2026-09-30
- Blocking
Signature missing or signed date invalid
evidence ·1572 § 8 · signature absent
- Blocking
ICF not accepted (blocks IRB gate)
evidence ·ICF v4 uploaded · not yet accepted
- At risk
Document uploaded but not yet accepted
evidence ·Financial disclosure · proposed, awaiting review
Findings are proposals, not resolutions. Accept or dismiss. Every disposition writes to the audit log.
Built for teams accountable to FPI.
Whether you run activation in-house or through a CRO, GreenLight replaces spreadsheet trackers and inbox threads with evidence-based readiness across every site, every day.
Shorter path to first patient in
Track activation cut vs. baseline per site. See which gates are open, which findings are blocking, and where slip is accumulating before it hits the timeline.
CTAs review findings, not packets
Validation surfaces only discrepancies that need a human decision. Clean documents flow through; your team works the exceptions.
Context-aware agent
Built-in agent reads your program snapshot, sites, gates, and open findings, then proposes concrete next steps. It never changes state without your approval.
Catch drift before IRB and SIV
Identity, version, credential, and signature checks fire when the document lands, not in the final QC pass.
Sponsor and CRO share one picture
Same readiness board, same evidence citations. Quality conversations move from "I think Site 14 is close" to "Site 14 is blocked on ICF v3 vs protocol v4."
Every status is evidence-backed
Ready, At Risk, and Blocked each point to a specific document, page, and field. Nothing is opinion.
PHI-free. Audit-ready. Built for regulated operations.
GreenLight handles regulatory and essential documents. Never patient data. Every change is logged, versioned, and tenant-isolated. The built-in agent proposes actions; humans approve every mutation.
PHI-free by design
Tracks FDA forms, IRB approvals, credentials, and signed protocols. Not patient records. PHI exclusion is architectural, not a policy checkbox.
Immutable document history
Every upload is versioned and preserved. The current approved version is always clear; prior versions stay queryable for audit.
Tamper-evident audit trail
Human and system actions append to a hash-chained, per-tenant log. The chain cannot be silently rewritten.
Tenant isolation
Multi-tenant row-level security ensures sponsor and CRO workspaces never cross. Enforced at the database, not just the UI.
See activation readiness live
across every site.
Early access is open to sponsor and CRO clinical-operations teams running multi-site activations. Tell us about your studies; we'll respond within 48 hours.