Life Sciences Biostatistics
Biostatistics services from SGS – collect, analyse and present your data in full compliance with the relevant regulations.
Why choose biostatistics from SGS?
We can help you:
- Optimise protocols with early trial support
- Acquire comprehensive statistical support, including statistical analysis, sample size calculation, statistical reporting, and more
- Achieve continuity and flexibility of study deliverables with our large, stable and highly qualified team
- Use our templates for Statistical Analysis Plan (SAP) and mock Tables Listings Figures (TLFs)
- Gain high-quality analysis within short timeframes, using our library of over 60 validated SAS macros
- Ensure compliance between the used Study Data Tabulation Model (SDTM) and our in-house Analysis Data Model (ADaM) principle of harmonisation
- Benefit from our broad range of therapeutic experience
Comprehensive biostatistics services from a world leader
We offer you unrivalled expertise in biostatistics and a broad range of therapeutic experience.
Our services include:
- Design and sample size calculations of clinical trials of any kind, including protocol reviews and co-authoring
- Adaptive trial designs support
- (e)CRF design input
- Analysis of all types of data – from pre-clinical, and clinical trials to epidemiological trials, following a variety of designs respecting the SAP and mock TLFs
- Programming of CDISC ADaM datasets, TLFs and metadata, ready for inclusion in the electronic Common Technical Document (eCTD)
- Interim analyses and defining stopping rules, including an independent statistician for unblinded interim analyses
- Pooling of studies, including safety and efficacy summaries for regulatory submissions
- Independent statistician participating in the Data Monitoring Committee (DMC) board and/or generation of the DMC analysis
- CSR review and programming of case narratives / patient profiles
- Preparing clients to present results to the FDA and EMA
To discuss your biostatistics requirements, contact us today.