It removes the retyping and the binders, not the people. Your investigator, your statistician, and your QA still review and sign off. What goes away is the chain of hand-offs that loses time and lets errors in.

Every engine reproduces a published reference, from PowerTOST for sample size to ICH Q1E for stability. That is not a claim you have to take on trust: the console carries the reference values and reproduces 610 of 610 of them on every load, and there is a button that deliberately bends each engine so you can watch the checks go red and then come back. It also generates a qualification report and a validation pack you can hand to QA. The hosted build adds the full computer system validation record.

Yes. It runs on your own machine and saves to your own disk. Nothing is sent anywhere, which suits a centre that keeps subject data inside its own walls.

No. In the local app everything stays on your machine, in a file you control, with a backup of the previous save kept beside it.

Open a study, paste a protocol, and you have a study spine and a set of documents in minutes. A working demo on one of your own protocols takes about an hour.

An AFMC alumnus and IIT Bombay Biodesign Fellow who worked as a bioavailability and bioequivalence investigator. It comes from the clinic floor.