Biostatistics That Move
Clinical Programs Forward
From study design through regulatory submission, Biostat Core provides the statistical rigor and global expertise your clinical program demands.
What We Do
End-to-end biometrics and clinical data services across the full trial lifecycle.
Biostatistics
From study design and power calculations through final CSR reporting, our biostatisticians deliver the analytical rigor regulators expect.
Learn more →Statistical Programming
CDISC-compliant SDTM and ADaM datasets, validated TLFs, and submission-ready data packages built in SAS and R.
Learn more →Data Management
EDC setup, CRF design, data cleaning, medical coding, and database lock — everything needed to deliver audit-ready clinical data.
Learn more →One Partner. Five Continents. Every Major Regulatory Pathway.
As the U.S. arm of Meta Clinical Technology, Biostat Core gives you local partnership backed by a global team of nearly 1,000 professionals. Our teams work across FDA, EMA, NMPA, and TGA submissions, bringing multinational regulatory fluency to every engagement.
Trusted by Leading Innovators
Latest Insights
Understanding ICH E9(R1) Estimands in Clinical Trials
April 10, 2026
The estimand framework transforms how we define and communicate trial objectives. Here's what every clinical team needs to know.
Read more →Regulatory5 Keys to a Successful FDA Submission Package
March 28, 2026
A complete, well-structured submission package can make or break your regulatory review timeline. These five principles guide our approach.
Read more →Statistical ProgrammingCDISC Compliance from Day One: A Programmer's Guide
March 14, 2026
Building CDISC-compliant datasets retroactively is painful and expensive. Here's how to bake compliance in from the start.
Read more →