Biometrics Services: Biostatistical Solutions

Biometric Services

More Than a Vendor — Your Partner in Progress

Clinical development runs on data. But without the right approach, that data can cease to be an asset. Statnomos’ Biometrics solutions blend therapeutic expertise, statistical rigor, and flexible models to help sponsors hear what their data is really saying — and use it to make smarter decisions, faster.

Benefits of Working With Statnomos

Accelerated Development Img
Accelerated Development

Without compromising quality

Built-in Compliance Img
Built-in Compliance

With CDISC, GxP, and FDA/PMDA expectations

Flexible Delivery Models Img
Flexible Delivery Models

Full-service, FSP, or consultative

Cross-functional Expertise Img
Cross-functional Expertise

Spanning biostatistics, programming, and regulatory

Multilingual Fluency Img
Multilingual Fluency

With CDISC, GxP, and FDA/PMDA expectations

The Statnomos Difference: Data That Delivers

At Statnomos, we engineer high-efficiency analytics solutions that streamline clinical data workflows while unlocking powerful insights. Whether it's data consolidation, automation, validation, or regulatory submission support, our goal is to help sponsors turn complex data into strategic intelligence that accelerates trial timelines and improves outcomes.

What sets us apart is our fusion of advanced technology with deep domain knowledge. Our multilingual programmers are skilled in SAS and open-source languages like R and Python, ensuring flexible, compliant solutions. Every project is led by senior-level statisticians who bring therapeutic expertise and data science leadership — ready to scale with your program, your infrastructure, and your goals.

Biostatistics + Statistical Programming

At Statnomos, we combine regulatory-compliant programming with modern statistical methodologies using open-source tools. Our experienced team ensures reliable analysis and submission-ready deliverables across every trial phase.

  • Design and author Statistical Analysis Plans (SAPs) using CDISC and regulatory standards
  • Build analysis datasets (SDTM/ADaM) using R and Python pipelines
  • Develop high-quality Tables, Listings, and Figures (TLFs) with open-source tools
  • Support mock data reviews, dry runs, and interim analyses
  • Automate validation and ensure traceability for global submissions
  • Support ISE and ISS across integrated submissions (FDA, EMA)
  • Perform statistical consulting for trial design and protocol development
  • Convert legacy formats and ensure dataset up-versioning with compliance
  • Deliver programming support for publications, CSR appendices, and ad-hoc analysis
  • Every Statnomos engagement is guided by scientific rigor, reproducibility, and audit-ready documentation — ensuring statistical integrity from design to delivery.

Standards-Driven, Submission-Ready

We’ve helped shape the standards that drive the industry forward:

  • CDISC Leadership: Our team contributes to ADaM guidance and TAUGs
  • Rigorous QC: Everything from SAPs to final TFLs is independently validated for consistency and accuracy
  • Audit-Ready Outputs: End-to-end compliance checks with full traceability