Late Phase Clinical Biostatistics

SGS’s mission in biostatistics is to offer clinical and statistical expertise from the design of the study protocol, to the data collection tools and all the way up to reviewing the clinical research report.

SGS’s Statistics Department advises, plans, and delivers on time analyses to optimize drug development.

Consulting and Planning
For 15 years, clients have benefited from an expert staff of 20 statisticians, who work with clients in Clinical Research, Statistics, SAS programming and latest relevant regulatory guidance. All SGS statisticians have a special degree in (bio) statistics; and SAS programming skills are trained by the SAS Institute itself. Clients come to SGS for a full statistical development plan or just several of its components.

• What must be investigated in this study?
  Thorough statistical review of the protocol has become a key component in increasing study quality. Design, sample size calculations, and discussions on choice of parameters all work together to design an optimal protocol
• Is this really the data we want to collect?
  A statistician questions whether the data in the CRF will be collected in the right way, and especially if the collected data will really be able to answer the questions that lie beneath your protocol’s objectives
• We have the data, now what?
  The Statistical Analysis Plan (SAP) defines in detail how the statistical analysis will be structured and what exactly it will contain. To prevent bias, the SAP has to be final and signed off before database lock (ICH-E9). The SAP can be extended to include Mock TLFs (tables-listings-figures). SGS has developed templates for the SAP and Mock TLF. Contact us to find out what they look like!

Delivering
SGS’s team of professionals develops the TLFs in SAS according to the specifications in the SAP.

CDISC ADaM formats are followed as a standard. SGS can even share a draft set of TLFs (a blinded testrun) before database lock, and discuss the contents. Programming can also be done according to clients own standards.

To speed up analysis time, while reducing costs for clients, 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 deep review of the Clinical Study Report (CSR) ensuring coherence and quality.

Services Include

• Randomization lists and code-breaking envelopes
• Central Randomization (fax-based system – do ask our experts when you consider using this)
• 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: SAP and programming
• Classical and population PK/PD analysis. (include link to PK/PD)
• Performing 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 for subjects who died, had an SAE or stopped because of an AE
• 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®)