The Foster City company that turns the chaos of drug-development data into something the FDA can actually read.
CAPTION: The logo of a company most patients will never hear of - and whose software the FDA's own reviewers open every day. Quiet plumbing for a loud industry.
Right now, in a beige federal building, an FDA toxicologist is squinting at a dataset from a study that ran on three continents. Different labs. Different machines. Different spreadsheets that never agreed on what a "day" was. The reviewer needs it all to line up. It does - because the software on the screen was built by about 190 people you have never heard of.
That is the strange position PointCross Life Sciences occupies. Drug development produces an avalanche of data: animal toxicology, clinical trials, biomarkers, bio-samples. Almost none of it is born in the same shape. Regulators, sensibly, demand a common format - CDISC's SEND for nonclinical work, SDTM and ADaM for clinical. Getting from "raw lab output" to "regulator-ready dataset" is tedious, unglamorous, and absolutely unskippable. PointCross built a business out of doing exactly that, and doing it well enough that the regulator itself became a customer.
The headline number says it all: roughly one in four FDA SEND submissions passes through PointCross software. The company also holds a contract to supply the FDA's own reviewers with the hosting, visualization and search environment they use to read nonclinical submissions. It is a rare thing - selling the referee the whistle and selling the players the cleats.
Founder and CEO Suresh Madhavan started the company in 2007 and kept it privately held. There is no nine-figure raise here, no blitz-scaling, no logo on a stadium. By public estimates the company has taken in under $2 million in outside funding while quietly embedding itself into the backbone of regulatory drug review. In an era addicted to growth theater, that restraint is almost the most interesting fact about it.
PointCross sells software and the expertise to run it. The flagship is XBIOM, a platform that walks data from ingestion to a regulator-ready package. Around it sits a validator, a repository, and a service that compresses weeks of work into days.
End-to-end study data platform: ingestion (VDR), a metadata repository (MDR), a unified data model, automated regulatory submission generation, and analytics for nonclinical and clinical data.
Semantically stitches clinical data, biomarkers, bio-sample availability and registry data into one place - so researchers can stratify cohorts and correlate findings in minutes, not weeks.
Checks SDTM, ADaM, SEND and Define.XML against FDA, CDISC and PMDA rules. One tool covering both clinical and nonclinical, for IND, NDA and BLA prep.
A Hadoop-based clinical data repository for SDTM data, with built-in workflows, validation and packaging for eCTD M5 submission folders.
Delivers validated, submission-ready SEND datasets and study reports for toxicology studies in 2-3 weeks, with real-time monitoring along the way.
Dataset preparation, QC, automated SDTM/ADaM generation, legacy data digitization, and regulatory data review delivered by a global team.
A "technical rejection" means a regulator bounces a submission before a human even reads the science - a costly, embarrassing delay. PointCross frames its whole pitch around making that number zero. The bars below sketch the company's footprint (figures are company-reported and third-party estimates; treat as approximate).
The reviewer scrolls. The columns line up. The units match. The animal IDs reconcile across labs that never spoke to each other. The study that took years and three continents reads, on screen, like it was always one tidy thing. The reviewer nods, moves on, and never thinks about the software - which is exactly the point.
PointCross spent nearly two decades making the most boring step in drug development disappear. No stadium logo, no nine-figure raise, no slogan you'd repeat at a party. Just a quiet wager that if you do the unglamorous part better than anyone, the industry - and the regulator - will quietly route a quarter of its most important paperwork through you. They have. That is the whole story, and it's hiding in a column that finally lines up.