We’ve made it our mission in biostatistical analysis to offer clinical trial development and statistical expertise from the design of the study protocol, through the data collection tools, all the way to reviewing the clinical research report.
Biostatistics Consulting and Planning
For 15 years, our clients have benefited from an expert staff of 20 statisticians who work with clients in Clinical Research, Statistics, SAS programming and latest regulatory guidance.
All SGS statisticians have a special degree in [bio] statistics, and they are trained by the SAS Institute itself in programming. Our clients may come to us for a full statistical development plan or just several of its components.
SGS’s team of professionals develops the TLFs in SAS according to the specifications in the biostatistical analysis plan.
CDISC ADaM formats are followed as a standard. SGS can even share a draft set of TLFs (a blinded test run) before database lock, and discuss the contents. Programming can also be done according to clients own standards.
To speed up statistical analysis time, and reducing costs, SGS uses its library of over 60 validated SAS macros. SAS programs can be delivered at the end of the project, together with a catalogue of compiled macros. After delivering the statistical analysis, the SGS statistician follows through with a review of the Clinical Study Report (CSR) ensuring coherence and quality.
Our Biostatistical Analysis solutions include:
- Randomization lists and code-breaking envelopes
- Central randomization
- Design and sample size calculations of clinical trials of any kind; including protocol reviews and co-authoring
- Analysis of all types of data from pre-clinical, clinical and epidemiological trials, following a variety of designs: Statistical Analysis Plan and programming
- Classical and population PK/PD analysis
- Interim analyses and defining stopping rules, including providing an independent statistician for your unblinded interim analyses
- Pooling of studies, including safety and efficacy summaries for regulatory submissions
- Data Monitoring Committee: independent statistician for the DMC and/or DMC analysis
- Clinical study report review and programming of case narratives
- CDISC SDTM database conversion programming
Biostatistic Software tools
- SAS® 8.2 & 9.1
- PROC StatXact® 6.2
- Sigmaplot facilities, for macro creation and statistical reporting
- Sample size software (nQuery Advisor®, PASS®, Data TreeAge®)
Contact SGS today to learn how we can help with your biostatical analysis requirements.Email us