Bioequivalence operating system

One system, from protocol to verdict. Not forty documents passed round by hand.

A bioequivalence study runs on retyping, binders, and a quote built in a spreadsheet at midnight. Intelligent CroW replaces all of it with one record, built on a CRO floor, that carries the study to the answer.

Built by an AFMC alumnus and IIT Bombay Biodesign Fellow, from the clinic floor.
Average bioequivalencePASS
80.00 100.00 125.00 90% CI of GMR, Test / Reference (%) 102.4%
PE 102.4 · CI 94.1 to 110.9N = 28 · CV 24%
Speaks the language of the agencies you answer to.
US FDAEMAUK MHRAWHO‑PQCDSCO
The way it works today

The study runs on paper, retyping, and luck.

  • xThe protocol gets retyped into the CRF, the schedule, the database, and the labels by different people. Each pass is a fresh chance to introduce an error.
  • xThe bioanalytical output is keyed into SAS by hand, then QA hunts the typos for weeks.
  • xQuality lives in binders. Signatures are wet ink. The QA stamp is pressed onto every page by hand.
  • xWhere a study stands, who is on it, what comes next, all of it lives in someone's head.
  • xThe quote is cobbled together in Excel with the margin half-guessed.
  • xWhen a page is reprinted, nobody logs it. When data is dropped, nobody records why.

Every one of these is a place to lose time, money, and data integrity. The upgrade is not a faster version of the manual way. It removes the hand-offs.

Meet the CroW

One CroW. All the Work.

Paste the protocol and the CroW gets to work. It conjures the study spine and every document the study and your CRO require, from the case report form and consent to the meal records, screening sheets, adverse event forms, training logs, and discharge summaries. Not a fixed set. Whatever the study needs.

The clever bird does the retyping, the binders, and the sorting, so your people do the science and the sign-off.

Every document the study and your CRO require, conjured from the protocol.
What is inside

Three parts, one record that carries the study.

Built where the studies run

India-first. Fluent in every market you file in.

One study, mapped against five agencies side by side, so nobody re-checks the acceptance criteria by hand for each market.

CDSCO & NDCT 2019 SUGAM filings DPDP 2023 ICMR ethics WHO-PQ US FDA · EMA · MHRA
Book a working session

Bring a protocol. Leave with a study spine.

Run one of your own protocols through the console and watch the design, the documents, the analysis, and the verdict appear inside the same hour.