Clinical Trial Biometrics Services
Biometrics Services for Phase I, Phase II and Phase III Clinical Trials
TCR-Solutions provides clinical trial biometrics services for Phase I, Phase II, and Phase III clinical trials. As a UK CRO with global reach, we support sponsors with integrated biometrics capabilities that help ensure delivery of high-quality, analysis-ready, and submission-compliant data.
Our biometrics services cover data management, biostatistics, and statistical programming, ensuring continuity from protocol design through to database lock, analysis and final reporting.
Our Clinical Trial Biometrics Services Include:
• Development of data management plans and database design
• EDC build, validation, and maintenance across industry platforms
• Medical coding (MedDRA, WHODrug)
• Statistical Analysis Plan (SAP) development
• Sample size calculations and randomisation strategies
• Statistical programming in SAS and R
• CDISC-compliant datasets (SDTM, ADaM) and define.xml
• Clinical Study Report (CSR) preparation
We work closely with Clinical Trial Protocol Design, Clinical Trial Regulatory Affairs, and Clinical Trial Project Management Services to ensure biometrics strategy is aligned with study objectives and regulatory requirements.
Why Biometrics Matters in Clinical Trials
Biometrics plays a central role in the successful delivery of Phase I, Phase II and Phase III clinical trials where data quality is fundamental to:
• Regulatory approval
• Clinical decision-making
• Programme progression
Poor biometrics processes can lead to:
• Delays in database lock
• Incomplete or inconsistent datasets
• Increased regulatory queries
At TCR-Solutions, our clinical trial biometrics services support:
• Accurate and consistent and submission ready clinical trial data
• Efficient database build, lock, analysis and reporting
• Alignment with global data and reporting standards
• Reduced risk of rework or regulatory queries
Frequently Asked Questions
Do you support Biometrics for Phase III clinical trials?
Yes. We provide clinical trial biometrics services across Phase I, Phase II and Phase III clinical trials, including large and multi-country studies..
What is included in your clinical trial biometrics services?
Our biometrics services include data management, database design, EDC build, medical coding, biostatistics, SAP development, statistical programming, CDISC dataset preparation and CSR support.
Do you provide CDISC-compliant datasets for regulatory submission?
Yes. We prepare CDISC-compliant datasets, including SDTM, ADaM and define.xml, to support regulatory submission requirements.