3 wedges
First CRO scope
BD & quotation assist, bioanalysis document review, and CTD Module support — not a full CRO ERP replacement.
Case study · Anonymized · CRO
CRO quotation, bioanalysis & CTD assist
An illustrative design-partner narrative for a mid-size CRO: faster study scoping drafts, bioanalysis package review assist, and CTD-oriented submission support — with sponsor data staying on-prem and experts accountable for every outbound deliverable.
HITL
Sponsor-safe gates
No auto-send of quotes or dossiers to sponsors. AI drafts; BD, lab, and RA leads approve.
On-prem
Sovereign posture
Protocols, bioanalytical data, and draft CTD text stay inside an approved CRO environment.
CRO identity and sponsor names are withheld. Metrics and outcomes are design-partner / MVP framing — not guaranteed turnaround, win-rate, or submission success.
Who (anonymized)
A regional contract research organization running clinical bioanalysis and regulatory document support for pharma/biotech sponsors. Teams juggle RFPs, study protocols, chromatogram-heavy bioanalysis packages, and CTD-aligned submission text under tight confidentiality.
Pain
- BD cycles where quotation and study-scope drafts take days of expert time across templates and prior studies
- Bioanalysis report packages that still need manual cross-checks across instrument PDFs, LIMS exports, and narrative sections
- CTD-oriented drafting that must stay consistent with sponsor instructions and frozen guidance — without leaking data to public LLM APIs
- Need for audit trails when sponsors or QA ask how a draft was produced
MVP shape — three assists under one Harness
01
BD & quotation
Ingest RFP / protocol synopsis; draft scope, assumptions, and quote narrative with citations to prior templates.
02
Bioanalysis review
Assist review of instrument PDFs and data-package checklists; escalate exceptions to lab scientists.
03
CTD support
Draft CTD-oriented sections with guidance citations; no auto-filing; RA sign-off required.
04
Provenance
Decision log: sources, model/pack versions, and reviewer actions for sponsor or QA inquiry.
What “good” looks like in an MVP
- Faster first-draft quotations with mandatory BD review before sponsor send
- Higher checklist completeness on bioanalysis packages vs a gold-label sample set
- Uncertainty escalation when evidence is weak — no silent “complete” status
- Zero auto-submission of CTD packages in the pilot window
Why it matters for Ivertiq
- Completes the Life Sciences peer set with a CRO-shaped narrative alongside MAH and forensic
- Reuses the same Harness control layer (orchestration, validation, provenance, HITL) with a CRO Validation Pack
- Shows sponsor-boundary discipline that CROs need when evaluating on-prem AI
What we do not claim
- Guaranteed RFP win rates or shorter every-study turnaround
- Replacement of BD, bioanalytical, or Regulatory Affairs judgment
- Full eCTD publishing or LIMS write-back in the first MVP