Biostatistics

Involvement of Biostatistical Analysis at the start of clinical trial development is a key component in increasing the quality of the study design and the resulting data. SGS' experienced statistics team works together with clients to develop the optimal protocol, capturing the right information.

Clear statistical analysis plans are established in agreement with the client and analysis is performed in accordance with international guidelines: CPMP, FDA and ICH. SGS' team of professionals then develop tables, listings, and graphs (TLGs) to be included in a final statistical report or clinical research report.

Biostatistical Services

• Central Randomization
• Analysis of all types of data from pre-clinical, clinical and epidemiological trials, using a variety of designs
• Classical and population PK/PD analysis.
• Interim analyses / stopping rules
• Design and sample size calculations of clinical trials
• Use of validated SAS macros
• Pooling of studies (including ISS/ISE)
• Safety data on subpopulations
• Efficacy data submission.
• Data Safety Monitoring Board (DSMB)

Software tools

• SAS®
• WinNonlin®
• NonNem®
• StatXact®
• Sigmaplot facilities, for MACRO creation and statistical reporting
• Sample size software (nQuery Advisor®, PASS®, Data TreeAge®)