Services
 CDISC Implementation Consulting Services

CDISC Data Creation Services
【CDISC Implementation Consulting Services】
EXiCARE’s extensive experience and know-how can help you overcome your problems.
（Example) ・CDISC training
・Analyze your current status and identify issues in migrating to the CDISC standard
・Support you in defining a procedure that complies with the CDISC standard
【CDISC Data Creation Services】
SDTM Data
Creation Support
•Data Sources
⇒
SDTM Data Creation
ADaM Data
Creation Support
•SDTM or Other ADaM
Data Sources
⇒
ADaM Data Creation
Pharmaceutical
Companies
Protocol
Case
Report
Form
DB
Definition
SAP
Data
Sources
TLFs
Mock-up
Analysis
Results
Review Specifications
（Conduct meetings as required and as appropriate）
CAC EXICARE
SDTM
Mapping
Specification
SDTM
Data
Creation
ADaM
Mapping
Specification
SDTM
sas
Validating Datasets
using OpenCDISC
SDTM
.xpt
ADaM
Data
Creation
ADaM
sas
Validating Datasets
using OpenCDISC
ADaM
.xpt
● The names of companies and products above are the trademarks or registered trademarks of their respective companies.
Past Experience
 SDTM Data Creation Support
 ADaM Data Creation Support
【SDTM】
Performed trials with more than 100 studies focusing on SDTM data creation from clinical data.
 Number of Studies : About 110
 Major Phases
: Phase Ⅰ～Ⅲ, post-marketing surveillance trials
 Therapeutic Area : Cardiovascular, Gastrointestinal, Ophthalmology, Dermatology,
Endocrine (Urology), etc.
 Target Versions
: SDTM v1.3 SDTM Implementation Guide 3.1.3
SDTM v1.4 SDTM Implementation Guide 3.2
【ADaM】
Created data for ADaM-based analysis as part of the statistical analysis process.




Number of studies :
Major Phases
:
Therapeutic Area :
Target Versions
:
About 20
Phase I ～ Ⅲ
Cancer, Neuropsychiatry, Gastrointestinal, Dermatology, etc.
ADaM v2.1 ADaM Implementation Guide v1.0
Support Example
 CDISC Implementation Support Service
Client Request

Identifying the issues in migrating the business processes to the CDISC standard.
Solutions
1.
2.
3.
4.
Analyze CDASH data and generate reports complying with the CDISC standard (SDTM, ADaM, Reporting).
Confirm how consistent existing process analysis charts are with those of the CDISC process.
Generate a Traceability Record to enable data lineage from the reports back to the CDASH data.
Review the adequacy of the CDISC process and list up issues and items to be considered.
CDASH
Data
SDTM
Mapping
Specification
SDTM
Data
ADaM
Mapping
Specification
ADaM
Data
Analysis
Program
Specification
Analysis
Results
Generate Traceability Record
Contact:
CAC EXICARE Corporation
CAC EXiCARE is your IT and business partner working closely with the
pharmaceutical industry to ensure a healthy and happy tomorrow.
CAC EXICARE Corporation
24-1 Nihonbashi-Hakozakicho, Chuo-Ku,
Tokyo 103-0015, JAPAN
TEL: +81-3-6667-8032
E-Mail: pharma-bto@cac.co.jp
URL: http://www.exicare.com
●
The names of companies and products above are the trademarks or
registered trademarks of their respective companies.