The system of actionfor clinical trials.
- I.Medidata made the record digital.
Case report forms stopped being paper.
- II.Veeva moved the documents.
The binder, the site file and the submission went online.
- III.Nobody runs the trial. That is the work we build for.
Reading the protocol into every system, catching the deviation, pricing the amendment, proving it afterwards.
An operating layer that lets software and AI do the work of a trial without inventing anything. Live on one paid study.
Madison, Wisconsin · October 2026
Three eras
Two companies made the record digital.Neither of them runs a trial.
Medidata digitized the data.
Case report forms stopped being paper. What changed was where the data lived.
Veeva moved the documents.
The binder, the site file and the submission became hosted, versioned and shared. What changed was where the documents lived.
AccuraTrials runs the trial.
Reading the protocol into every system, catching the deviation, pricing the amendment, proving it all afterwards: still done by people, once per system. That work is what we build software for.
What it costs now
The tax on a documentno machine can read.
Move the sliders. Every amendment is paid again in every system that has to re-read the protocol.
- $535Kto implement one substantial amendment
- 3.5substantial amendments per Phase III protocol, on average
- 25%of a trial budget reported for source data verification
14 amendments, each re-typed into every system that reads the protocol. Every re-typing is a place two systems can come to disagree.
Amendment cost and frequency: Tufts Center for the Study of Drug Development. Source data verification: Funning 2009; Andersen 2023. Industry averages, not a measurement of this platform.
Why this holds
Three thingsthat compound.
- Provenance is the architecture.No path through the system skips it, so trust compounds study over study.
- Study logic is reusable.The next phase of the same molecule starts from the model, so modelling is paid roughly once across a program.
- CROs are the channel.We are not replacing the people who run trials. We are building the system they run on.
Illustration: modelling effort per study across one program.
Today
Where weactually are.
- In a studyLive on a paid clinical study.Accura Studio built it, and AccuraTrials EDC is running it.
- On the baseUSDM-native, on OpenStudyBuilder.Accura OS reaches the EDC today, with four more systems connected as prototypes.
- WhereMadison, Wisconsin.Founded 2025. No outsourced engineering.
What it is for
What a faster trialis actually for.
Five in every hundred rare diseases have an approved treatment.
- Rare diseases described
- ~7,000
- With no approved treatment
- ~95%
- People living with one
- ~300M
What a trial costs decides what a company will attempt. More cures, sooner.
Approximate figures widely cited by NIH (NCATS) and rare-disease organizations.
Come lookat the model.
Thirty minutes on the real platform. Bring a protocol if you have one.
Or email us: jgui@accuratrials.com