Summary of Statistical Service Offerings

TechSoft Group’s Statistical Consulting Division provides a wide array of biostatistical, and biomedical services including descriptive, inferential, univariate and multivariate data analyses, hypothesis testing, experimental design and clinical trials, preparation of manuscripts, review of publications, survey sampling and other methods related to biomedical research.
Our team members are key contributors to the development of Industry data interchange standards, particularly CDISC SDTM and ADaM standards. To contact our Statistical Consulting Division, send an email to stats@techsoftgroup.com.

Biostatistics and SAS Programming Services:
TechSoft's team consists of experienced Biostatisticians and SAS Programmers with advanced training in Biostatistics and Public Health. Our team has:

• Experience and training in clinical trials, clinical outcomes, epidemiology, health care resource utilization, and public health surveillance
  
• Led several clinical trial submission projects including US and MAA
  
• Led the design and analysis of Clinical Trials, Health Outcomes and Economic Research, Epidemiology, Resource Utilization, and Survey Sampling studies.
  
• Experience with longitudinal data analysis, analysis of variance modeling techniques, categorical data analysis, factor analysis, cluster analysis, parametric and non-parametric testing, classification and regression trees, principal components, survival analysis, time series analysis, and survey sampling.
  
• Worked with several large epidemiology databases including the National Inpatient Sample (NIS), National Health and Examination Nutrition Survey (NHANES), and the Framingham Heart Study
  
• SAS certified programmers that can
  

  -		Support clinical submission teams in the production of clinical study report deliverables, as well and the production of Module 5 deliverables within the eCTD, including Data Definition Tables, Define.XML, SAS transport files, Annotated Case Report Forms
  -		Lead the implementation of Infrastructure systems that support clinical trials data management and analysis (SAS Drug Development and Data integration Studio)
  -		Assist clients develop in-house reporting systems for the generation of clinical study analyses.

CDISC Standards:
Our standards implementation team consists of Principals that have:

• Been key contributors to the CDISC SDTM and ADaM standards development teams for 10 years
  
• Received the FDA leveraging and collaboration award, and Outstanding achievement awards for CDISC
  
• Developed efficient processes for mapping legacy studies into SDTM
  
• Led Industry wide teams that conducted pilots with the FDA to vet the integrity of the CDISC SDTM/ADaM standards (CDISC FDA ADaM Pilot Project)
  
• Submitted several SDTM compliant studies to the regulatory agencies
  
• Built frameworks to support client data standardization efforts