Biostatistics services harness our proprietary time-saving technologies and algorithm libraries to deliver robust insights fast for projects of any size, smoothing the path to market approval.
Biostatistics tailored to your needs
We provide customised biostatistics support, expertise and partnerships across multiple therapeutic areas for developers of all sizes.
Study design & protocol development
We offer a uniquely targeted approach to clinical study design and protocol development with our study simulation software, KerusCloud.
Statistical analysis planning & execution
We deliver all statistical activities for studies, expediting analysis strategies for final study reporting, interim analyses, SDAC/IDMC/DSMB support and the implementation of CDISC standards.
Biostatistics tailored to your needs
We provide customised biostatistics support, expertise and partnerships across multiple therapeutic areas for developers of all sizes.
Study design & protocol development
We offer a uniquely targeted approach to clinical study design and protocol development with our study simulation software, KerusCloud.
Statistical analysis planning & execution
We deliver all statistical activities for studies, expediting analysis strategies for final study reporting, interim analyses, SDAC/IDMC/DSMB support and the implementation of CDISC standards.
In the last year :
growth in revenue
growth in client base
of studies reported in CDISC standards
Our biostatistics services include:
- Full service or independent biostatistics and programming support
- Support for translational studies
- Statistical analysis planning and execution
- Implementation of estimands framework
- Randomisation services
- Sample size / power calculations
- Adaptive and fixed study design and protocol development
- Review of data management and validation
- QC/QA for data
- Support for risk-based monitoring (RBM) approaches
- Interim analyses and data monitoring boards
- Functional service provision (FSP)
- Production of Tables, Listings, and Figures (TFLs) using ADaM or Analysis Ready Datasets
- Production of CDISC SDTM Packages including datasets, annotated CRF (aCRF.pdf), define (define.xml), and reviewer guide (csdrg.pdf)
- Production of CDISC ADaM Packages including datasets, define (define.xml), and reviewer guide (adrg.pdf)
- Support for meetings with regulatory authorities
- Preparation of integrated safety and efficacy summaries for regulatory submissions
- Post-regulatory submission support
- Input for publications
