Veractra

Submission-ready CSRs. Every claim verified. Every sentence traced. On your Cloud.

AI-powered Clinical Study Report generation that your medical writers, reviewers, and regulatory teams can trust. ICH E3-compliant CSRs in days - with every numerical claim verified against your source TLFs, every sentence traceable to its origin, and deployed entirely on your cloud.

Days, not months
Every claim verified
Zero data exposure

CSR creation is still slow, fragmented, and resource-heavy.

A Clinical Study Report sits at the intersection of the most complex documents in clinical development - Protocols, SAPs, TLFs, and Investigator's Brochures. Hundreds of pages of data, synthesized into a single regulatory-grade narrative.

For most teams, the process still runs on manual effort.

  • Cross-referencing data by hand across multiple source documents
  • Weeks spent drafting and reformatting, section by section
  • Hundreds of numerical values QC'd against TLFs manually
  • Review cycles scattered across emails, comments, and document versions
  • A persistent shortage of experienced medical writers that compounds with every concurrent trial

The outcome hasn't meaningfully changed in a decade.

  • Drafting timelines of 6–15 weeks per report
  • High per-report cost driven by rework, review cycles, and specialist constraints
  • Numerical inconsistencies and version-control gaps that invite regulatory queries
  • Limited trust in existing AI tools - because speed without verifiability doesn't solve the real problem

The CSR process doesn't need to be reinvented. It needs to be relieved of its manual weight - by AI that's purpose-built for regulated medical writing, where every number is verified, every sentence is traceable, and every output is built to withstand health authority scrutiny.

That's the bar Veractra is engineered to meet.

The four pillars of Veractra.

01

Verified

Every number checked. Every mismatch surfaced.

02

Traceable

Every sentence linked to its source. One click to see exactly where it came from.

03

Your Data. Your Cloud. Your Control.

Veractra runs inside your environment - not ours.

04

Human-Governed

AI generates. Your experts decide. No document leaves without sign-off.

From source documents to submission-ready CSR.

Veractra takes your source documents - Protocol, TLFs, Investigator's Brochure, and SAP - and moves them through a structured, end-to-end pipeline. Every step is visible. Every output is auditable. Nothing is a black box.

Platform features

Veractra ingests your Protocol, SAP, TLFs, and IB, and builds a study-specific knowledge base inside your infrastructure. Writers query it conversationally - every answer cited back to the source.

Draft section-by-section content aligned to ICH E3, with support for your own sponsor templates.

Every numerical value is cross-checked against your source TLFs, with mismatches flagged and confidence scores assigned. Every sentence traces back to its document, section, and page. Provenance, not summaries.

Author → Reviewer → Approver workflow with inline comments, AI-summarized digests, and approval-gated export. Nothing leaves the platform without sign-off - all captured in an immutable audit trail built for 21 CFR Part 11 and ICH E6(R3).

Deploys inside your cloud. Trial data never leaves your infrastructure.

See Veractra in action.

We'll walk through everything - from document upload through verified, export-ready CSR - including how Veractra deploys inside your own environment.