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Medical Writing Center

AI-assisted authoring for CSRs, IBs, DSURs, protocols and labels.

Ask AI Forecast
Documents in draft
47
AI-assisted drafts
29
Pending review
12
Avg turnaround days
6.3
↓ 62%

Document registry

New document
DocumentTypeTrialVersionAuthorStatusDue
CSR-204
CSR
ONCO-204v0.4L. Romero
Draft
Aug 30Open
IB-307
IB
ONCO-307v4.1AI + R. Patel
In Review
Jul 18Open
DSUR-118
DSUR
RD-118v2.0AI Draft
Draft
Sep 02Open
PROT-411
Protocol
CARD-411v1.2J. Tanaka
Approved
—Open
ICF-204-EU
ICF
ONCO-204v3.0Legal
Submitted
SubmittedOpen

AI Document Builder — CSR-204

1. Synopsis100%
Source: Protocol v3.2
2. Ethics100%
Source: IRB submissions
9. Investigational Plan78%
Source: Protocol + EDC
11. Efficacy Evaluation54%
Source: ADaM ADTTE
12. Safety Evaluation41%
Source: ADAE + SAE log
16. Appendices12%
Source: TMF

AI Assist

Review & approval