EU Joint Clinical Assessment demo

Turns the EU assessment scope into a PICO grid (evidence, gaps, the section that answers each PICO and its next step on the 100-day clock) and drafts the cited dossier. 1:14

What the demo shows

An EU HTA solution for market access teams that builds the JCA dossier and its PICO answers.

A scope parser turns the assessors' scope into one row per PICO with the Member States behind it. An evidence mapper fills the eight outcomes of every row from CSRs, outputs and published trials, and marks rows with no head-to-head data in red. A feasibility analyst proposes an indirect comparison or a justified gap for each; the biostatistician recommends and the dossier lead decides. Each row is owned by one dossier section and carries its next dated step on the 100-day clock. A writer drafts the sections with every number cited, and a checker compares numbers and SmPC wording before each signed version.

Transcript

  1. EU Joint Clinical Assessment builds the JCA dossier and its PICO answers for market access teams.
  2. The dossier is due 100 days after the scope, every PICO answered.
  3. Corventa's scope has 11 PICOs.
  4. Agents fill each row with its outcomes and evidence.
  5. Two rows turn red.
  6. No head-to-head data against the comparators Germany asked for.
  7. The 100-day clock is on every row.
  8. Both decisions are due in seven days.
  9. Lena opens Pico 2.
  10. Dostaxel links the trials, but prior immunotherapy differs.
  11. She approves it with a sensitivity analysis.
  12. The hazard ratio is 0.92.
  13. Pico 2 turns blue and its section is ready to draft.
  14. A full draft by day 39.
  15. Build on Botminds, agents, data, screens, and governance on one platform.

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