PointCross — Orchestrating Study Data for the Modern BioPharma Industry
25%
of FDA SEND submissions powered by PointCross
10+
years validating regulatory study datasets
3
agencies covered — FDA, PMDA & CDISC
2–3wk
study reports + SEND with Single Track Processing
Lifecycle coverage

Solutions for every stage of drug development

From discovery to post-market, PointCross has the products, solutions and services that fit each step of the journey.

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Services

Or have our team run it for you

Data-as-a-service across standardization, quality assurance, managed delivery, and legacy studies.

Data Quality Assurance
Independent QC to keep datasets submission-ready.
Legacy Studies
Bring historical trial data into the modern stack.
Why PointCross

Built for regulated study data

Low-touch, no-code

A highly automated platform generates, validates and reconciles datasets with minimal manual effort.

Compliant by design

21 CFR Part 11 records controls and conformance to FDA, PMDA and CDISC rules across the lifecycle.

Proven at scale

Powering 25% of FDA SEND submissions, with over a decade validating regulatory study data.

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See XBIOM on your study data

Schedule a call to explore how PointCross drives efficiency across your clinical and nonclinical R&D.