Questions for your CRO, with the evidence, before you file.
Intelligent CroW offers a fixed-fee integrity screen of one completed, outsourced bioequivalence study. CroW staff run it on data you supply. You receive a report that lists questions for the CRO, each with the evidence behind it, and a verification package that you or an inspector will be able to check with the free offline verifier. The verifier is a prototype, is not yet distributed, and as built for release today returns Does not reproduce for every package.
You file on evidence that someone else produced.
A CRO runs the study, analyses the samples and writes the report. You file it under your name. If that evidence fails later, the loss is yours.
The CRO's own report, and an audit that sampled its systems and records at one point in time.
A separate look at the study data, from someone the CRO does not pay, before you file.
One study in. Questions and a checkable package out.
Completed, not yet filed
You choose one completed study that a CRO ran for you. Studies not yet filed come first, while there is still time to ask the CRO and hear its answer.
For the CRO, with evidence
Each finding is a question for the CRO that names the records it rests on, so the CRO can answer from its own files. The report accuses no one and makes no regulatory determination.
A package an inspector will be able to check
The report comes with a verification package. A free offline verifier is being built to show whether the package is unchanged and whether the statistics CroW recorded in it reproduce. It is a prototype and is not yet distributed. As built for release today it returns Does not reproduce for every package.
No CRO access, no pooling
Only CroW staff run the screen. No CRO ever gets access to it, and your subject-level data are never pooled with another sponsor's.
Status: prototype. The screen, the report, the package and the verifier have run on synthetic studies only.
The generic sponsor that outsources a bioequivalence study.
A completed study that you have not yet filed comes first. A study you decided not to file, or one that failed, comes second. A filed study is screened only after your regulatory head and your counsel have signed off on how any question would be handled. You send data you hold, or data you can ask the CRO for where your agreement with the CRO allows it. The screen is not for CROs. A CRO cannot buy it, run it or see it.
Being built so that you can check CroW's work, not take its word for it.
Paid by the sponsor, with no CRO fee on a screened or verified study
CroW works for the sponsor. It takes no fee from a CRO for any study it screens or verifies for a sponsor, and no CRO gets access to the screen.
A verifier that runs on a machine you choose
The free verifier runs offline, on your own computer or an inspector's. It is a prototype and is not yet distributed. A package without a timestamp from an authority outside CroW says so in the result. CroW does not yet obtain such a timestamp.
A package format you will be able to read
CroW will publish the package format, so anyone can read what a package holds. Until then the format is confidential.
Numbers checked against reference packages
The statistics engine is checked against frozen outputs of the reference R packages. All 1,417 checks pass on the current build. The verifier reruns the same engine, so agreement shows that a result repeats, not that someone recalculated it independently.
A second screen of the same study shows in the record
If CroW screens the same study again, the new package lists every earlier CroW screen recorded under the same study description. A later reviewer can see that the study was screened before. Screens run by anyone else are outside what a package can show. Until CroW takes a timestamp from an outside authority, the list rests on CroW's own records alone.
Withdrawn questions stay on the record
An operator may withdraw or merge a question. The report states how many questions were raised, kept, merged and withdrawn, and the package carries every one.
These statements describe the prototype as tested on synthetic studies. Intelligent CroW was founded by a physician who worked as a bioavailability and bioequivalence investigator.
The screen works for the sponsor, and only the sponsor.
A screen that a CRO could run on its own data before sending it would teach the CRO what to hide. So no CRO ever gets access to it.
Fixed limits on who runs it and where your data go
Only CroW staff run the screen. There is no self-service version. CroW takes no fee from a CRO for any study it screens or verifies for a sponsor. Your subject-level data are never pooled with another sponsor's data. CroW never alters a concentration, a time or an identity in your data. It never says whether a study is bioequivalent. What you do with a question stays your decision, taken with your own regulatory and legal advisers.
A checking tool that the checked party can rehearse against.
No CRO access, no self-service, no pooling across sponsors.
- CRO access to the screen
- Self-service screens
- A fee from a CRO for a study CroW screens or verifies
- Pooling one sponsor's data with another's
- A regulatory determination
The limits, stated before you ask.
- It cannot prove whose plasma is in a vial. A substituted sample that was analysed faithfully can look like any other sample.
- It does not show that the study was conducted properly or that the data are true.
- It does not decide bioequivalence and makes no regulatory determination.
- A question in the report is not a finding against the CRO. The CRO may have a full answer.
- A screen that raises no question has not shown that a study is free of error. In CroW's own tests on synthetic studies, the screen did not raise a question on every problem seeded into them.
- CroW states no performance figure for the screen, and no real study has been screened yet.
- It covers only the data you supply. Records you do not send are not screened.
- It gives no legal advice. What you do with a question is your decision, taken with your own counsel.
The software reads the data. A person asks the question.
A CroW operator can keep, merge or withdraw a question, and records a reason each time. No number in a report comes from a language model. Any language model CroW uses runs on CroW's own machine.
Your quality team reads the questions, decides which to put to the CRO, and keeps the evidence on file.
Three pages, each short.
The independence policy
Who runs the screen, who never gets access, where your data sit, and who may pay CroW.
What the free verifier checks
What its two result labels mean, what they do not mean, and how to ask for a copy.
One study, one fixed fee
No price is published. Ask about a pilot on one completed study that you have not yet filed.
Tell us about one completed study you have not yet filed.
A first conversation needs no study data.