Cross-document findings
Dose inconsistencies, undefined abbreviations, codename variants, population mismatches — caught across every module before submission.
Not spell-check. Cross-document reasoning.
Chrona Bio Enterprise
Submission readiness for the team that owns the IND.
Chrona Bio reads across every document in your submission, tracks section state and sign-off, and gives your regulatory lead a single view of whether the package holds together — before the deadline becomes a crisis.
Existing customer? Sign in02 — Who this is for
Built for the regulatory operations lead who owns the submission.
She assembles, harmonizes, and ships the package. CMC writes Module 3. Clinical writes Module 5. She's the person who knows the dose in the summary needs to match the dose in the protocol — and she's the one who gets the Information Request when it doesn't.
Her tools today: SharePoint, Word, Outlook threads, a Gantt chart kept in a tab that's been open for nine months, and a contractor she pays to format tables the week before submission.
Nothing in that stack reads across the package the way a regulator does. Which means the night before submission, the question does this hold together? has only one answer: read all 1,400 pages again, and hope.
03 — What Chrona Bio Enterprise does
Five things Chrona Bio does that no other tool in your stack does.
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Section and document state
Unresolved tracked changes, open comments, missing section owners, documents that changed after sign-off — surfaced at both document and section granularity.
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Audit trail
Every finding, every dismissal, every override — logged with actor, timestamp, rationale, and SHA-256 checksum. The inspection-ready record is a byproduct of normal use.
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Continuous readiness monitoring
As documents change, the readiness picture updates. You know the state of the submission today, not just the night before it goes out.
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Chrona Pro for every seat
Every Enterprise seat includes the Chrona Pro Word add-in. Findings from Enterprise surface in the writer's ribbon — they see what Chrona flagged without leaving Word.
Contextual surfacing · coming soon
04 — Where your documents already live
Your documents stay where they are.
Chrona Bio reads from your SharePoint via the Microsoft Graph API — read-only, in-tenant, no content copied to Chrona Bio infrastructure. Your IND files never leave your environment.
You bring your own Anthropic or OpenAI API key. Document text sent to LLMs is governed by your API terms under zero-retention agreements. Chrona Bio stores hashes and metadata. Never content.
Sharepoint today. Veeva integration in active development — recruiting design partners now.
05 — The workflow
Chrona reads. Humans write. Humans decide.
01
Detect
Chrona reads across documents as they change. Inconsistencies, state changes, and drift are flagged automatically.
Chrona Bio · continuous
02
Route
Findings are surfaced to the right person — section owner, regulatory lead, or the whole team depending on severity.
By role · by section
03
Judge
A human reviews every finding. Dismiss with rationale. Override with documentation. The system never decides — it informs.
Regulatory lead · the call
04
Log
Every judgment is recorded. Actor, timestamp, rationale, document state at time of decision. The audit trail writes itself.
Append-only · SHA-256
The record is a byproduct of normal use
06 — Built for regulated work
Part 11 is the architecture, not a checkbox.
01 · Audit ledger
Append-only audit log with SHA-256 checksums on every row.
Nothing is silently rewritten. Every finding, dismissal, and override is recorded with actor, timestamp, and a content hash that proves the row hasn't moved since it was written.
02 · Mandatory rationale
No dismissal without a reason. Server-validated. Ten characters, minimum.
Every finding closed by a human carries the why. The rule is enforced on the backend, not the frontend — so it can't be bypassed by an impatient browser session.
03 · Prompt versioning
Every cached LLM result tagged with the immutable prompt version that produced it.
A finding from January is reproducible in July. Prompt drift is captured, versioned, and never silently overwritten — so a result you signed off on stays a result you signed off on.
04 · Readiness snapshots
Snapshots bind document hashes at declaration. If a document changes, affected sign-offs invalidate.
You can't sign off Tuesday and have the section quietly change Thursday without anyone knowing. The snapshot pins what was true at the moment of decision, and flags the moment that truth shifts.
07 — Where this is going
The IND is the first surface. The same intelligence layer reads across the rest of the evidence chain.
Submission readiness is what Chrona Bio does today, because that's where the deadline pressure is sharpest. But the underlying capability — reading across documents, tracking state, holding humans accountable for the call — extends to every place a small biotech has to make a decision against scattered evidence.
Now
In production
Submission readiness
Cross-document findings, section state, sign-off ledger, and audit trail across the IND package — running today at design-partner sites.
Next · 2026
Design partners shape it
Clinical operations readiness
The same cross-source reading applied to protocol amendments, IB updates, CSR alignment, and site-by-site monitoring evidence — so the clinical record holds together the way the IND does.
On the horizon
Direction · not commitment
Lab and CMC manufacturing
One readiness picture across the full evidence chain — batch records, stability data, lab notebooks, vendor COAs — reasoned against the submissions they support. We're talking to partners who want this.
Today's scope is the IND. The rest is the design-partner conversation.
08 — Design partner pricing
We're taking on design partners now.
The first five design partners get founder-level attention — direct access to Brian and Flavia, weekly check-ins during onboarding, and early access to every feature before it ships.
Design partner pricing is not a discount. It's a different commercial relationship. Direct influence on what we build next — the friction in your submission process becomes our prioritized work. We move at your timeline. Currently working with Lumen Bioscience and a small number of others.
Five partners. We're selective because we have to be — at this stage, every customer relationship is a product relationship.
5 slots 3 open