Software for Making Mock Tables, Metadata Document, SAS Table Programs of Statistical Analysis

Plan, and eCRF pages of EDC System

ClinTrialStat IncClinTrialStat Inc..

Copyright @2007 ClinTrialStat Inc. All rights reservedCopyright @2007 ClinTrialStat Inc. All rights reserved

Application Software Developed by ClinTrialStatApplication Software Developed by ClinTrialStat

SapMaker products for making text contents, mock tables SapMaker products for making text contents, mock tables and figures, metadata documents, and table SAS code of and figures, metadata documents, and table SAS code of

Statistical Analysis Plan (SAP):Statistical Analysis Plan (SAP): 1.1. SapMaker-Table 3.4 – for mock tables/figures and SAS codeSapMaker-Table 3.4 – for mock tables/figures and SAS code

2.2. SapMaker-Content 2.0 – for text contentsSapMaker-Content 2.0 – for text contents

3.3. SapMaker-Metadata 2.4 – for metadata documentSapMaker-Metadata 2.4 – for metadata document

eCRF – Builder 1.0: making internet/intranet based eCRF – Builder 1.0: making internet/intranet based electronic case report form (eCRF) of electronic data capture electronic case report form (eCRF) of electronic data capture (EDC) system(EDC) system

SapMaker-Content: Easily make individual SAP sectionsSapMaker-Content: Easily make individual SAP sections

SapMaker-Content: using search engine feature to quickly find SapMaker-Content: using search engine feature to quickly find related information from other documentrelated information from other document

SapMaker-Table: Quickly making individual mock tables and SapMaker-Table: Quickly making individual mock tables and figures of SAPfigures of SAP

Machine automatically created mock tableMachine automatically created mock table

SAS Coder: Easily making table SAS codeSAS Coder: Easily making table SAS code

SAS Coder: Easily making table SAS codeSAS Coder: Easily making table SAS code

Easily making mock figureEasily making mock figure

Machine created mock figureMachine created mock figure

SapMaker-Metadata: Quickly making metadata document for SapMaker-Metadata: Quickly making metadata document for analysis datasets following CDISC standardsanalysis datasets following CDISC standards

Machine created metadata document following CDISC standards (in Excel file)Machine created metadata document following CDISC standards (in Excel file)

Machine converted metadata document to Define.xml for e-Submission Machine converted metadata document to Define.xml for e-Submission

eCRF Builder: Quickly making Internet/Intranet based eCRFseCRF Builder: Quickly making Internet/Intranet based eCRFs

Machine created eCRF pageMachine created eCRF page

Machine created the eCRF page corresponded CDISC ODM Define.xml fileMachine created the eCRF page corresponded CDISC ODM Define.xml file

Created machine readable ODM Define.xml file for e-submissionCreated machine readable ODM Define.xml file for e-submission

SapMaker special language feature: Making table in ChineseSapMaker special language feature: Making table in Chinese

Created mock table in ChineseCreated mock table in Chinese

Use SAS Coder created real table in ChineseUse SAS Coder created real table in Chinese

Service of ClinTrialStatService of ClinTrialStat HelpHelp clients customize the SapMaker software products, such as clients customize the SapMaker software products, such as

modifying the templates of mock tables of SAP, and SAS macros modifying the templates of mock tables of SAP, and SAS macros for creating analysis tables, to meet the specified needs or the for creating analysis tables, to meet the specified needs or the standards of the clients; standards of the clients;

Help Help clients customize the eCRF-Builder software product, such clients customize the eCRF-Builder software product, such as modifying the templates of eCRF pages, to meet the specified as modifying the templates of eCRF pages, to meet the specified standards of the clients for CRFs; standards of the clients for CRFs;

Make eCRF pages for clients;Make eCRF pages for clients;

Make SAP, metadata, and/or SAS table codes for clientsMake SAP, metadata, and/or SAS table codes for clients

Users of ClinTrialStat Software ProductsUsers of ClinTrialStat Software Products Department of Biostatistics, Harvard School of Public Health, Boston, MA Department of Biostatistics, Harvard School of Public Health, Boston, MA

02115 02115

Vertex Pharmaceuticals, Inc., Cambridge MA 02139Vertex Pharmaceuticals, Inc., Cambridge MA 02139

Millennium Pharmaceuticals, Inc. Cambridge, MA 02139Millennium Pharmaceuticals, Inc. Cambridge, MA 02139

Novo Nordisk Inc., Princeton, New JerseyNovo Nordisk Inc., Princeton, New Jersey

d.s.h. statistical services GmbH, Rohrbach, Germanyd.s.h. statistical services GmbH, Rohrbach, Germany

US Army Medical Research and Materiel Command, Ft. Detrick, MD 21702-US Army Medical Research and Materiel Command, Ft. Detrick, MD 21702-50125012

University Eye Center, Duke University, Durham, NC 27710University Eye Center, Duke University, Durham, NC 27710

Department of Medical Biostatistics, University of Vermont, Burlington, VT Department of Medical Biostatistics, University of Vermont, Burlington, VT 0540505405

Department of Biostatistics, University of South Florida, Tempa, FLDepartment of Biostatistics, University of South Florida, Tempa, FL

Ockham Development Group, Inc., Cary, NC 27511Ockham Development Group, Inc., Cary, NC 27511

License Price of SapMaker Software ProductsLicense Price of SapMaker Software Products

1.1. SapMaker-Table 3.4 – $698 for per PC install * SapMaker-Table 3.4 – $698 for per PC install *

2.2. SapMaker-Content 2.0 – $98 for per PC install SapMaker-Content 2.0 – $98 for per PC install

3.3. SapMaker-Metadata 2.4 – $498 for per PC SapMaker-Metadata 2.4 – $498 for per PC install install

4.4. For academic users, there is a 25% discount on For academic users, there is a 25% discount on price of license. price of license.

* Not include SAS macros* Not include SAS macros

About Us:About Us:Mission:Mission:ClinTrialStat provides statistical data analysis of clinical trials through ClinTrialStat provides statistical data analysis of clinical trials through application solution products and application solution products and professional services. professional services. It is our mission to It is our mission to provide services and products of excellent quality that offer cost-effective provide services and products of excellent quality that offer cost-effective solutionsolutions.s.

Products:Products: SapMaker-Content 2.0, SapMaker-table 3.4, Sapmaker-Metadata 2.3, and eCRF-SapMaker-Content 2.0, SapMaker-table 3.4, Sapmaker-Metadata 2.3, and eCRF-Builder 1.0Builder 1.0

Services:Services: Customize SapMaker software products to implement standards of customers, develop SAP, Customize SapMaker software products to implement standards of customers, develop SAP,

Programming SAS tables, and eCRF web pagesProgramming SAS tables, and eCRF web pages

Company Information:Company Information:ClinTrialStat IncBelle Mead, New Jersey 08502, USAPhone: 908-938-8330, Fax: 908-359-3583Email: clintrialstat@yahoo.com, Web: http://www.sapmaker.com Asian Branch Office: ClinTrialStat China, Ltd.

125 East Ming Road, New Technique Development Zorn, Kunming, Yunnan, China