One address for every enquiry.
Write to drvarshith21@gmail.com about a pilot integrity screen of an outsourced bioequivalence study, about the verifier, or about anything else. This site has no contact form. A first conversation needs no study data, so please send none by email.
Pick the subject line that fits.
Pilot enquiry
A fixed-fee screen of one completed, outsourced bioequivalence study. Tell us whether the study is filed yet. No price is published. The fee is agreed in writing before any data move.
Verifier review request
The verifier is not a download. A review copy can go only to a named recipient under a signed confidentiality agreement, with synthetic test packages only. None has been supplied yet.
General enquiry
Questions about the independence policy, about what the screen cannot show, or about this site.
The screen is not offered to CROs. A CRO cannot buy the screen, run it or get access to it.
The things people ask first.
The screen does not assume that your CRO is unreliable. It gives your quality team a separate look at the study data before you file.
No. It raises questions for the CRO, each with its evidence. It makes no regulatory determination.
It cannot prove whose plasma is in a vial. It does not show that the study was conducted properly or that the data are true. It covers only the data you supply. A screen that raises no question has not shown that a study is free of error.
No. Only CroW staff run it, and no CRO ever gets access to it. You decide which questions to put to the CRO.
That is why completed studies that are not yet filed come first. A filed study is screened only after your regulatory head and your counsel have agreed in writing how any question would be handled. CroW gives no view on your legal obligations.
No. The screen, the report, the package and the verifier are prototypes and have run on synthetic studies only.