Protocol Design Optimization demo
Every draft protocol on one board, each section colored by the amendment it is likely to need, and each flag beside the past amendment it resembles. 1:13
What the demo shows
A trial design solution for study teams that flags protocol sections likely to be amended.
Five reviewer agents (eligibility, schedule and burden, endpoints and estimands, safety monitoring, operational feasibility) and a lead reviewer read each draft section by section against the sponsor's own archive of past amendments, its design standards and ICH E6(R3), E8(R1) and E9(R1). Every draft sits on one board, each section colored by its strongest open finding; each finding cites the protocol line and the past amendment it resembles, with the months and cost that amendment took. Named owners accept or reject each finding, the protocol lead signs, and the committee pack is built from the decisions.
Transcript
- Protocol Design Optimization shows study teams which protocol sections will likely be amended.
- Most protocols get amended at about half a million dollars each in Phase 3.
- Each draft is a column of sections, colored by risk.
- VLT 305 meets the committee in 7 days, at 73%.
- Its population section has 3 findings, each beside the amendment it resembles.
- symbols. Two failed biologics.
- VLT-204 broadened that same criterion after losing four months.
- Maya opens the protocol line and accepts the suggested wording.
- Risk falls, and the committee PAC lists each decision with its evidence.
- Avoidable amendments, fixed before the committee meets.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.