Bioforum provides high-quality customized biostatistical services tailored to your study’s needs through timely and accurate data analysis.
Following the review of your study’s requirements, we will determine the best methods for collecting, analyzing and presenting the data, all in compliance with industry regulations and standards.
Our Biostatistics group includes experienced statisticians and clinical programmers who keep current with guidance updates and developments as they pertain to ICH, FDA (CDER and CBER) and other regulatory agencies.
Statistical programming services are provided exclusively with SAS® software.
Biostatistical and clinical programming services Include:
- Assistance with study design
- Sample size determination
- Randomization Plan
- Development of Statistical Analysis Plan (SAP)
- CDISC – data conversion
- SDTM –Study Data Tabulation Model
- ADaM –Analysis Data Model
- SEND – Standard for Exchange of Nonclinical Data
- SDTM-MD – Study Data Tabulation Model for Medical Devices
- Documentation for submission – define.xml and Reviewers Guides
- Legacy studies
- Data conversion to CDISC standards
- Prepare Legacy study data for submission
- Documentation for submission – define.xml and Reviewers Guide
- Statistical analysis of clinical data –
- As part of INDs, IDEs, NDAs, 510Ks, PMAs, ANDAs and BLAs
- Study Interim analysis
- Custom analysis per customer/regulatory agencies requirements
- Meta-analyses of multiple sources
- Programming of tables, listings and figures (TLFs)
- Clinical programming for integrated safety and efficacy summaries (e.g., ISS/ISE)
- Statistical representation and programming of TLFs as part of data monitoring and safety meetings (DMC/DSMB/DSMC)
- Clinical programming support for periodical reports (e.g. DSUR)
- Statistical reports