1. Using SAS Enterprise Guide Add-In to Enable Guided Statistics Bas van Bakel OCS Consulting, the Netherlands © OCS Consulting

2. Agenda © OCS Consulting SAS Enterprise Guide (SAS EG) Business Drivers SAS EG add-in Client Case Technology Summary

3. SAS Enterprise guide © OCS Consulting “SAS Enterprise Guide provides a SAS graphical interface that helps you exploit the power of SAS and publish dynamic results in a Microsoft Windows client application. The solution is the preferred SAS interface for business analysts, programmers and statisticians and a key application in SAS Business Intelligence offerings.” Source: www.sas.com

4. © OCS Consulting SAS Enterprise guide

5. Business Drivers © OCS Consulting NOTOX: Founded in 1983 and evolved as a privately held company until 2005; Specializes in personalized contract research and consultancy for the registration of pharmaceutical products and (agro)chemicals worldwide; More than 280 specialists and 11.700 m2 of modern purpose built laboratories and offices are available to perform regulatory toxicology studies.

6. Business Drivers © OCS Consulting OCS Consulting created validated system for storing and reporting research data: Data are collected in a standard way. Standard reports are generated. Special Studies: Specific measuring device is used to collect data and the structure of the data therefore differs from the structure required by the validated system. Specific statistical analysis is to be performed on the research data. Further analysis depends on intermediate results and unforeseen exploratory analysis may be needed. Reports are generated outside validated structure.

7. Business Drivers © OCS Consulting Stand Alone ApplicationSAS Enterprise Guide

8. Business Drivers © OCS Consulting Stand Alone ApplicationSAS Enterprise Guide Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis

9. Business Drivers © OCS Consulting Stand Alone ApplicationSAS Enterprise Guide Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis No SAS/database structure knowledge needed for users SAS/database structure knowledge needed

10. Business Drivers © OCS Consulting Stand Alone ApplicationSAS Enterprise Guide Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis No SAS/database structure knowledge needed for users SAS/database structure knowledge needed User guided with custom made interface screens No custom made user interface screens

11. Business Drivers © OCS Consulting Stand Alone ApplicationSAS Enterprise Guide Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis No SAS/database structure knowledge needed for users SAS/database structure knowledge needed User guided with custom made interface screens No custom made user interface screens ‘Decision steps’ can be implementedHard to implement ‘Decision steps’

12. Business Drivers © OCS Consulting Stand Alone ApplicationSAS Enterprise Guide Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis No SAS/database structure knowledge needed for users SAS/database structure knowledge needed User guided with custom made interface screens No custom made user interface screens ‘Decision steps’ can be implementedHard to implement ‘Decision steps’ Possible to validate entire application once Validation needed for each project individually

13. Business Drivers © OCS Consulting Stand Alone ApplicationSAS Enterprise Guide Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis No SAS/database structure knowledge needed for users SAS/database structure knowledge needed User guided with custom made interface screens No custom made user interface screens ‘Decision steps’ can be implementedHard to implement ‘Decision steps’ Possible to validate entire application once Validation needed for each project individually No link with SAS Architecture/metadataUse of SAS Architecture/metadata and SAS EGuide style sheets

14. Business Drivers © OCS Consulting Stand Alone Application SAS Enterprise Guide SAS Enterprise Guide Add-In Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis No SAS/database structure knowledge needed for users SAS/database structure knowledge needed User guided with custom made interface screens No custom made user interface screens ‘Decision steps’ can be implemented Hard to implement ‘Decision steps’ Possible to validate entire application once Validation needed for each project individually No link with SAS Architecture/metadata Use of SAS Architecture/ metadata and SAS EGuide style sheets

15. Business Drivers © OCS Consulting Stand Alone Application SAS Enterprise Guide SAS Enterprise Guide Add-In Unforeseen exploratory analysis is not possible Possible to perform unforeseen exploratory analysis No SAS/database structure knowledge needed for users SAS/database structure knowledge needed SAS/database structure knowledge needed only for exploratory analysis User guided with custom made interface screens No custom made user interface screens User guided with custom made interface screens ‘Decision steps’ can be implemented Hard to implement ‘Decision steps’ ‘Decision steps’ can be implemented Possible to validate entire application once Validation needed for each project individually Add-In can be validated once; validation needed for exploratory analysis No link with SAS Architecture/metadata Use of SAS Architecture/ metadata and SAS EGuide style sheets Use of SAS architecture/ metadata and SAS EGuide style sheets

16. © OCS Consulting SAS EG Add-in Input AnalysisOutput

17. © OCS Consulting SAS EG Add-in

18. © OCS Consulting SAS EG Add-in

19. Client Case © OCS Consulting Approach: Per type of study a meeting with a study director of the particular area of interest is scheduled to discuss statistical methods. Step 1 - Investigate structure of input data; Step 2 - Determine study specific “decision tree”; Step 3 - Determine specifications and lay-out of output; Step 4 - Determine lay-out of user interface screens; Step 5 - Formalise User Requirement Specification.

20. Client Case © OCS Consulting Step 1 - Investigate structure of input data:

21. Client Case © OCS Consulting Step 2 - Determine study specific “decision tree”: Each parameter analysed separately Test Normality/Homogeneity Transformation/Exclusion of data Parametric/Non-parametric test Active groups vs Control group Positive Control group vs Control group Post-dose values vs pre-dose values

22. Client Case © OCS Consulting

23. Client Case © OCS Consulting

24. Client Case © OCS Consulting

25. Client Case © OCS Consulting

26. Client Case © OCS Consulting

27. Client Case © OCS Consulting Step 3 - Determine specifications and lay-out of output: Results of Normality/Homogeneity testing Results of (non-)parametric tests Listing of imported data (optional)

28. Client Case © OCS Consulting Step 3 - Determine specifications and lay-out of output: It should be possible to generate.pdf and Word files; Style should be similar to current application;

29. Client Case © OCS Consulting Step 3 - Determine specifications and lay-out of output:

30. Client Case © OCS Consulting Step 4 - Determine lay-out of user interface screens.

31. © OCS Consulting Client Case

32. Technology © OCS Consulting.NET framework 1.1; User interface developed in Visual Studio 2003; SAS Enterprise Guide version 4.1; SAS (Version 9.1.3) programs analyse and process the data; Communication between user interface and SAS programs mainly done with %LET statements, %INCLUDE statements and SAS datasets. Technology set up:

33. Technology © OCS Consulting

34. Technology © OCS Consulting %LET parname = EEP; %LET control = 1; %LET positive = NONE; %LET statdose = 0; EEP_NONE_DS.SAS7BDAT ALLPARMS.SAS7BDAT %LET transval = NONE; %INCLUDE global.sas; %INCLUDE normal_dunnett.sas; EEP_NONE_RESULTDS.SAS7BDAT

35. Technology © OCS Consulting Intermediate datasets will remain available after the session has been closed for further (exploratory) analysis

36. – 5 Days – 7 Days – 13 Days – 4 Days – 1 Day Project Metrics © OCS Consulting Team:.NET Programmer SAS Programmer / Project manager Statistician Effort: Design of the Application SAS Programming User Interface creation Documentation / Testing Project management + 30 Days

37. Summary © OCS Consulting Very well suited for repetitive data analysis requirements with similar looking data; Provides a validated, structured environment in which the user is guided through decision steps with the help of user interface screens; Possibility to perform additional exploratory analysis on imported or analysis-ready datasets using SAS Enterprise Guide functionality; All data processing/analyses performed with SAS; Easy to implement changes; Log files available.

38. Questions © OCS Consulting Web: www.ocs-consulting.com www.ocs-consulting.nl Email: sasquestions@ocs-consulting.com