Governed AI-Assisted CSR Authoring | CSR Studio

The Challenge

Reviewers and auditors cannot see where a CSR statement came from or how AI was used. Protocol amendments, SAP updates and TLF reruns arrive without a record of which CSR text depends on them, so amendment references risk going stale. Review runs sequentially, writer → biostatistics → clinical review, and consistency is checked by reading.

Key Challenges

AI use isn’t on the record: Nothing shows which statements AI produced, what they rest on, or how reliable they are.

Oversight spread across handoffs: Writer → biostatistics → clinical review leaves approval split across people and versions.

Checks leave no trace: Cross-document consistency is verified by reading, with no record of what was checked.

Numbers lack a verification record: About 150 TLFs are retyped into Sections 10–12 and hand-checked, with no proof of verification.

Our Solution

CSR Studio lets Regulatory Operations and QA adopt AI in CSR authoring without giving up control. Writers keep authorship, and a human approves every section before it moves on.

Every claim answerable:
Each statement and number is cited to study data, so a regulatory question (FDA, EMA, PMDA) points straight to its source.

Amendments stay current:
Stale protocol and amendment references are flagged before the CSR goes forward.

Independent verification:
A separate cross-check confirms every citation against the source value.

Automated QC before review:
Deterministic checks catch numeric mismatches and inconsistencies, so reviewers see a cleaner draft.

Risk-based review:
High / Medium / Low confidence ratings and SME routing direct effort to flagged items.

Key Impact

100%

Numeric statements designed to be traceable to their sources

3 confidence tiers

High / Medium / Low on every claim

The Customer

Regulatory Operations and Quality Assurance teams responsible for the CSR submitted to regulators (FDA, EMA, PMDA), working with medical writing and clinical review.

The Outcomes

Defensible Submissions:
100% of numeric statements are designed to be traceable to source, so Regulatory Operations can answer regulator questions with evidence.