Greenlightby Agros Systems
Backed byLeapYearLeapYearAfore CapitalAfore Capital

Catch essential-document issues before they delay first patient in.

Greenlight turns each protocol into site-specific startup requirements, validates submitted regulatory documents — identity, version, credentials, signatures — and gives sponsors a live command center for activation risk across every site.

Phase II Oncology Trial
Command Center · 32 sites
FPI riskHigh
8/ 32
Ready to activate
11/ 32
At risk
6/ 32
Blocked
StatusReasonEvidenceOwner
  • Blocked
    Site 014 · PI license expires before activation
    CTA
  • At risk
    Site 022 · ICF version mismatch
    Site
  • Blocked
    Site 031 · Missing delegation log
    Coordinator
  • Ready
    Site 008 · All requirements accepted
    Sponsor
Hash-chained audit · append-onlyProtocol v4 · IRB approved
Team experience from
  • Harvard Medical School · MIT HST
  • Columbia University · Vagelos College of Physicians and Surgeons
  • Howard Hughes Medical Institute
  • Emory Winship Cancer Institute
  • MD Anderson Cancer Center
  • Harvard Medical School · MIT HST
  • Columbia University · Vagelos College of Physicians and Surgeons
  • Howard Hughes Medical Institute
  • Emory Winship Cancer Institute
  • MD Anderson Cancer Center

Institution names describe prior team experience only. No endorsement or affiliation implied.

01The problem

Site activation breaks when document readiness is invisible.

Most startup teams know whether a document was uploaded. Far fewer know whether it is complete, current, consistent, accepted, and activation-ready.

That gap is where weeks of slip accumulate. Greenlight closes it.

  1. Uploaded
    Document submitted
  2. Accepted
    Required fields present
  3. Current
    Latest approved version
  4. Consistent
    Matches across documents
  5. Activation-ready
    Cleared for first patient in
02Workflow

From protocol to activation readiness.

One pipeline. Site-specific requirements at the front. Evidence-backed readiness at the back. A sponsor command center over the whole thing.

Protocol
PI CV
License
FDA 1572
Delegation log
01

Build the Blueprint

Greenlight reads your protocol and resolves a curated regulatory-template library into the exact requirement set for each site, each IRB, and each person — PI, sub-I, coordinator. No template fishing, no missed forms.

FDA 1572 · p. 1
Finding
PI name mismatch vs CV
02

Validate the evidence

Sites upload through a tokenized link — no login. AI plus deterministic checks reconcile identity across forms, catch protocol-version mismatches, and flag credentials expiring before target-ready. Every finding cites a document, page, and field.

Site 014ready
Site 022ready
Site 031risk
Site 008ready
03

Command the rollout

A live readiness rollup per site: days-to-ready, open findings, projected activation cut vs. baseline, and a stall score that predicts which sites are about to slip. IRB packets assemble on demand for WCG, Advarra, and local.

03What Greenlight catches

The issues Greenlight catches before they become delays.

Every finding carries a document, page, and field citation, plus a severity and confidence. Findings are discrepancies, never auto-fixes — an explicit human disposition writes its own audit event.

  • Blocking

    PI identity mismatch across 1572, CV, license, personnel

    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 requirement has no accepted document (blocks IRB)

    evidence ·ICF v4 uploaded · not yet accepted

  • At risk

    Required document uploaded but not yet accepted

    evidence ·Financial disclosure · proposed, awaiting review

04For sponsors

Built for sponsors who need real startup visibility.

Greenlight replaces spreadsheet tracking and inbox chasing with evidence-based readiness — across every site, on every day.

  • Shorter time to activation

    Move from “site selected” to “ready to enroll” with fewer review cycles. The dashboard tracks activation cut vs. baseline per site.

  • Lower review burden

    Validation surfaces only the discrepancies that actually need a human decision. Your CTAs review findings, not full packets.

  • Issues caught earlier

    Identity, version, credential, and signature checks fire the moment a document lands — not at the IRB or sponsor QC.

  • Real CRO oversight

    See the same readiness picture your CRO sees, evidence and all. Quality conversations move from anecdote to artifact.

  • Evidence-backed activation status

    Every status — Ready, At Risk, Blocked — points to a specific document, page, and field. Nothing is opinion.

  • Stall prediction, not just status

    Each site carries a stall score derived from missing docs, open blockers, overdue requirements, and chase history. You see slip risk before it hits.

05Compliance

Designed for sponsor-confidential, regulated workflows.

Greenlight is PHI-free by structural design, with immutable document versions, a hash-chained audit history, and per-tenant isolation enforced at the database row.

  • PHI-free by design

    Greenlight tracks regulatory evidence — FDA forms, IRB approvals, CLIA/CAP, credentials, signed protocols — never patient data. PHI-free is a structural boundary, not policy.

  • Immutable versions

    document_versions are immutable from insert. A current-version pointer tracks the latest approved release; the full lineage stays queryable for audit.

  • Hash-chained audit

    Every action — human or agent — appends to a per-tenant contiguous sequence with a SHA-256 prev-hash chain. The chain cannot be silently rewritten.

  • Tenant isolation

    Row-level security keyed on a JWT tenant claim, backed by same-tenant composite foreign keys so cross-tenant joins fail even from service-role code.

Stop guessing which sites will delay you.
See activation readiness, live.

Early access is open to a small cohort of sponsor clinical-operations teams. Tell us about your active studies and we’ll be in touch within 48 hours.