Medical Writing Quality Control demo

CSR QC, number by number: every result in a draft traced to its table cell, and every quote re-checked when a table is re-run. 1:13

What the demo shows

A medical writing QC solution for writers that checks each CSR number against source tables.

Agents find every number in a draft, match it to the exact TLF cell in the current run, check population, denominator, analysis and rounding against house rules, compare documents with each other, and trace every quote of a re-run table across all drafts; the QC lead decides each finding and signs the QC record.

Transcript

  1. Medical Writing Quality Control checks every report number against its table for QC teams.
  2. One efficacy section quotes 200 results.
  3. QC ticks each by hand.
  4. Each draft is a page.
  5. Each number is a page.
  6. Green agrees. Red does not.
  7. Then a late data query reruns the SBGA table.
  8. 66.6% becomes 66.4.
  9. One click shows the ripple.
  10. Nine quotes in six documents.
  11. Agents recheck each quote.
  12. Three settled, six still disagree.
  13. In the efficacy section, Lena checks the table cell and accepts 66.4.
  14. The fix goes to the writer.
  15. Reviewers decide only the mismatches and sign in about a day.
  16. Built on Botminds: agents, data, screens, and governance on one platform.

Transcribed from the film’s narration. Captions are on the player.