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Biostatistics you can defend

From study design to final analysis, our biostatisticians choose the right approach for your program and present results in the clearest way possible.

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Researcher working with data in a modern lab
Bio Statistics

Demonstrating efficacy in the clearest way possible

Biostatistics is necessary for all investigational drug or device development programmes to determine the efficacy and effectiveness in clinical trials. This includes the study designs, study conduct, determining the most effective data collection points and how analysis and reporting should be performed.

Sigma-Chi biostatisticians have a desire for quality and implement the best approach to a client situation or scenario to ensure correct analysis without an over-complex process. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible.

  • Protocol design and statistical sections
  • Sample size and power calculations
  • Randomisation schedules
  • Statistical Analysis Plans (SAPs) and mock shells
  • Study-level analysis and TLF review
  • Support for pre-clinical studies
Statistician reviewing analysis charts for SAPs and TLFs
Long-term partnerships

Lasting relationships, shared knowledge

Our personalized approach forms lasting relationships and enables our experts to transfer their biostatistics knowledge to our customers.

Expert Knowledge

Sigma-Chi has been built around the expert knowledge and reputation across the industry of our statistical consultancy team. Originally founded as a biostatistics contract research organization (CRO), biostatistical services have always been a key component of Sigma-Chi services as part of our heritage.

How we help

A range of biostatistics services

Study design consulting

Bespoke consultancy for protocol design, endpoints and estimands, so the study answers the right question.

Sample size & power

Robust sample size and power calculations, documented for regulators and ethics committees.

SAP & shells

Clear Statistical Analysis Plans and table shells agreed with your team before programming starts.

Analysis & reporting

Study-level analysis of tables, listings and figures, with interpretation support for the CSR.

Pre-clinical support

Advice for pre-clinical studies to ensure the study objective is fulfilled.

Therapeutic experience

Experience across therapeutic areas and all phases of development.

Biostatistics team reviewing study data together
Statistical report with charts under review
Statistician analysing clinical data on dual monitors
Therapeutic Experience

Across therapeutic areas and all phases

Sigma-Chi has experience across a wide range of therapeutic areas and all phases of research and development. Our scientific principles will guide you throughout your trial, ensuring high-quality data with your clinical trial reporting to support your regulatory submission.

Statistical programming lifecycle

From raw data to submission-ready outputs

Clinical programming is a connected chain of specifications, datasets and outputs. Sigma-Chi supports every stage, and automates quality checks where it matters most.

⚡AI TLF QC automatically checks every output
Step 1 · What happens here

Raw clinical data

Study data arrives from EDC systems, central labs, ePRO and other vendors, often in different formats and structures.

Reconciliation reportsData review listings
How Sigma-Chi helps
  • Data transfer review and reconciliation
  • Data cleaning and query support
  • External data integration
Final deliverablesDefine-XMLReviewer guides (SDRG · ADRG)Pinnacle 21 reportsCSR-ready TLFsSubmission package

Let’s Shape the Future of Your Clinical Studies Together

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