The independence policy.
Intelligent CroW's integrity screen of an outsourced bioequivalence study works for the sponsor that relies on the study, and for no one else in that study. This page states who runs the screen, who never gets access, where your data sit and who may pay CroW. Status: prototype. No real study has been screened yet, so these rules have been exercised on synthetic studies only.
Operator-run only. No CRO access. No self-service.
A screen that a CRO could run on its own data before sending it would teach the CRO what to hide. So the screen is a service, not software anyone outside CroW can run.
Three rules with no exceptions
Only CroW staff run the screen. No self-service version exists and none is planned. No CRO gets access to the screen, to its methods or to its settings. The methods and settings are never published and never printed in a report. A report shows the evidence behind each question, not how the record was chosen.
A checking tool that the checked party can rehearse against.
No CRO access, no self-service, operator-run only.
- CRO access to the screen
- Self-service screens
- Published screen methods or settings
- A regulatory determination
One completed study in. Questions and a checkable package out.
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.
Questions, not verdicts
Each finding is written as a question your quality team can put to the CRO. It names the records it rests on, so the CRO can answer from its own files. The report accuses no one, never says whether a study is bioequivalent and makes no regulatory determination. It prints its own limits under the heading What this screen cannot show.
The report comes with a verification package. You, your auditor or an inspector will be able to check that package 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.
A second screen of the same study shows in the record.
Every CroW screen of a study, in its package
CroW runs no screen off the record. If CroW screens the same study again, the new package lists every earlier CroW screen of it. A later reviewer, whether on your side or an inspector, 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, this history rests on CroW's own records alone.
An operator may withdraw or merge a question, and records a reason each time. The report states how many questions were raised, kept, merged and withdrawn, and the package carries every one with what was decided about it.
A study screened until the questions go away, with only the last screen on file.
Every earlier CroW screen of the study travels with the newest package.
One machine, a workbench with no outbound connection, no pooling.
On the operator's own machine
The screen runs in a workbench on the CroW operator's own machine. The workbench makes no outbound network connection. It is a prototype.
An encrypted store, with no telemetry
Inside the workbench store, study data are encrypted at rest. The files you send and the package CroW returns are ordinary files. CroW software sends no telemetry of any kind.
Identifiers the screen does not need are left out of what it reads
On import, direct identifiers of persons that the screen does not need are left out of the data the screens read, and the import report names each column left out. Your files are kept as received, in the encrypted store and in the package, which goes back to you. Subjects are known to CroW by the study's own subject key.
Your files are read, never edited
CroW never alters a concentration, a time or an identity in your data, and never changes a file you send.
One sponsor's subjects stay with that sponsor
No subject-level data from one sponsor are ever pooled with another sponsor's. A study whose sponsor differs from the sponsor of the engagement is refused at import.
None today
CroW hosts nothing today. When hosting arrives, each customer gets its own instance, hosted in India.
A verification package contains the study data you supplied. It goes to you. CroW gives it to no one else without your written consent.
The sponsor pays. The CRO pays nothing for a study CroW screens or verifies.
No fee from a CRO for any study CroW screens or verifies
CroW takes no fee from a CRO for any study it screens or verifies for a sponsor. The screen has one fixed fee, agreed with the sponsor in writing before any data move. No price is published.
CroW also has capture software, a prototype, that a CRO could run while it conducts a study. CroW supplies it to a CRO only under a written agreement that the sponsor sees. If the CRO behind your study was supplied with it, the sponsor report will say so.
A checker with a commercial tie to the party it checks, unknown to the sponsor.
No CRO fee on a screened or verified study, and any supply to a CRO disclosed to the sponsor.
Local only, and never the source of a figure
Any language model CroW uses runs on CroW's own machine. No study data are sent to a cloud model service. A model may put a computed result into plain words for a reader. Every number in a report comes from deterministic code.
A model that writes a number which looks computed but was not.
Numbers come from code. Words about them may come from a local model.
Tell us about one completed study you have not yet filed.
A first conversation needs no study data. Read what the screen cannot show before you write.