Biostatistics

Involvement of a biostatistician 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 for the targeted objective(s).

Clear statistical analysis plans (SAP) are established in agreement with the client. Analyses are performed in accordance with SGS SOPs and international guidelines (ICH, FDA, EMEA); especially ICH-E9. SGS’ team of professionals develop tables, listings, and figures (TLFs) to be included in the clinical research report.

Biostatistical Services:

• Statistical consultancy
• Design and sample size calculations of clinical trials
• Interim analyses / stopping rules
• Creation of randomization lists and code-breaking envelopes
• Central Randomization (fax-based)
• SAP development
• Analysis of all types of data from pre-clinical, clinical and epidemiological trials, following a variety of designs
• Classical and population PK/PD analysis.
• Library of validated SAS macros
• Derived datasets according to CDISC AdaM model
• Statistical reports (only upon request):
  • Topline results report
  • Statistical study report
• Review of the clinical research report
• Pooling of studies (including efficacy and safety summaries for regulatory submission)
• Data Safety Monitoring Board (DSMB)
  • Interim analyses for the DSMB
  • Independent statistician as DSMB member
• Conversion of legacy trials into CDISC SDTM

Software tools:

• SAS® 9.1
• PROC StatXact® 6.2
• Sigmaplot facilities, for macro creation and statistical reporting
• Sample size software (nQuery Advisor®, PASS®, Data TreeAge®)