Our Services

Clinical Trial Biometrics Services

Biostatistics, data management and statistical programming under one roof. Clean, analysis-ready datasets and CDISC-compliant submissions.

Clinical trial biometrics and data management

Biometrics

What We Deliver

TCR Solutions delivers clean, analysis-ready datasets and CDISC-compliant submissions.

We provide data management plans, EDC build and validation, medical coding (MedDRA, WHODrug), and biostatistics including SAP authoring, sample size and randomisation.

Our statistical programmers work in SAS and R to produce CDISC SDTM and ADaM datasets with define.xml, and we author clinical study reports (CSRs) — giving you submission-ready deliverables that satisfy MHRA, EMA and FDA requirements.

The Value

Why It Matters

Our biometrics capability delivers submission-ready datasets that satisfy MHRA, EMA and FDA, faster database lock and CSR delivery, and senior biostatistician input from day one.

With data management, biostatistics and programming under one roof, you get seamless integration and fewer handoff delays.

Biometrics value and submission readiness
Biometrics FAQ

FAQs

Frequently Asked Questions

Do you use CDISC standards? Yes — all datasets are produced in SDTM and ADaM with define.xml documentation.

Can you build the EDC? Yes — we build and validate EDC databases on common platforms including Medrio, Castor and REDCap.