To ensure accurate interpretation of scientific data, biostatistics is an essential element of any clinical development program. With one of the largest European teams of biostatisticians with advanced degrees, we offer you a wide range of biostatistics support, creative thinking and analysis optimized for your unique study designs. We review your study’s needs and determine the best methods for collecting, analyzing and presenting your data in compliance with regulatory guidelines.
Why choose biostatistics from SGS?
We can help you:
- Optimize 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 harmonization
- Benefit from our broad range of therapeutic experience
Comprehensive Biostatistics Services from a World Leader
We offer you unrivaled 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.