Biostatistics

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.

Delivering

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.

• Biometrics Services by SGS

  Leaders in Data Mgmt, Statistics & Medical Writing (PDF 99KB)
  Biometrics (98 KB)
• ADaM Design & Processing Services

  SGS is a registered solution provider for ADaM (PDF 97KB)
  ADaM Design (96 KB)
• SDTM Conversion Services

  SGS is a registered solution provider for SDTM (PDF 104KB)
  SDTM Conversion (104 KB)

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• SDTM & ADaM Hands-on Solutions

  Presentation from 2012 CDISC User Group
  SDTM & ADaM (1148 KB)
• ADaM 2.1 Implementation

  Presentation from 2011 CDISC Consortium
  ADaM 2.1 Implementation (1131 KB)

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All 7 resources

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  Biometrics

  published 02/29/12

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  ADaM Design

  published 02/29/12

  PDF

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  SDTM Conversion

  published 02/29/12

  PDF

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  Interactive Pocket Map

  published 06/14/13

  PDF

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  SDTM & ADaM

  published 05/16/12

  PDF

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  ADaM 2.1 Implementation

  published 05/16/12

  PDF

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  Electro-Medical Devices

  published 12/07/12

  PDF