AI-Assisted CSR Drafting for Clinical Research

The Challenge

Writers manually cross-reference the protocol, SAP, datasets & TLFs per section, hand-check every quoted number against TLF outputs, and reconcile safety/deviation narratives against logs by hand. Amendment references risk going stale, and writer → biostatistics → clinical review happens sequentially — a bottleneck before any submission-ready draft.

Key Challenges

Numbers are retyped, not referenced: Writers transcribe results from about 150 TLFs into Sections 10–12 and build summary tables by hand.

Consistency is checked by reading: Synopsis, body, Section 14, protocol, SAP, ADaM and SDTM are compared manually.

Changes are invisible: Protocol amendments, SAP updates and TLF reruns arrive without a record of which CSR text depends on them.

No audit-ready trail: Reviewers and auditors cannot see where a statement came from or how AI was used.

Our Solution

AI-assisted authoring of ICH E3 clinical study reports from approved study sources (protocol, SAP, TLFs, ADaM, SDTM etc.). Medical writers keep authorship; every generated sentence and number links back to its source, carries a High / Medium / Low confidence, and passes CDISC-aware consistency checks before review.

Ingest Finalized Study Inputs:
Protocol, SAP, datasets, TLFs, and safety/deviation/conduct records.

Cited AI Drafting:
Core ICH E3 sections drafted with a forced citation to source data on every claim.

Independent Citation Cross-Check:
Every citation verified against the actual source value before it stands.

Deterministic QC:
Flags numeric mismatches, stale references, terminology & population inconsistencies.

SME Routing, Human Sign-Off:
Flagged items route to the right SME; no section finalizes without human approval.

Key Impact

~13 working days saved

≈3 weeks per CSR (conservative; full cycle ~43 → ~30 working days)

30–70%

AI drafting time-reduction range: standard CSRs → heavier dossiers

The Customer

Medical writers, biostatistics and clinical reviewers preparing the CSR, the core clinical evidence package submitted to regulators (FDA, EMA, PMDA) for marketing authorization.

The Outcomes

Moves CSR effort from transcription and number cross-checking to scientific interpretation.

Faster First-Draft Turnaround

Industry benchmarks indicate that first-draft turnaround can be reduced from 2–3 weeks to 3–5 days, accelerating the preparation of QC-ready clinical study reports.