The 2nd Japan CDISC Group JCG Meeting

1
The 2ndJapan CDISC Group (JCG) Meeting

• 28 January 2004
• Yoshio Tsukada
• JCG Leader

2
Overview of JCG

• CDISC History in Japan
• JCG Membership Structure
• Expectations on CDISC in Japan
• Current and Future Activity

3
CDISC History in Japan

• Jan 2002 First introduction in Japan
• May 2002 CDISC Japan Meeting
• Nov 2002 J3C formed
• Jan 2003 JCG Kick-off Meeting
• Apr 2003 1st JCG Meeting
• May 2003 Activities started
• Jan 2004 2nd JCG Meeting

4
JCG Membership Structure

• Membership
• Two types of JCG Membership
• Contribute as a Corporate Sponsor/member Company
• Contribute as an Individual Volunteer
• Devotes his/her time to CDISC activities in Japan
• for the time being, and recommend to be a
  Corporate
• sponsor/member in the near future

5
Membership
63
65
56
51
41
6
65 Individuals from 40 Companies
As of January 1, 2004
Company
Individual
7
Structure of JCG
European CDISC Group
8
J3C

• Japan CDISC Coordinating Committee
• Mineko Fujimoto (Schering)
• Rieko Ichihara (Pfizer)
• Hiroaki Matsuda (Boehringer-Ingelheim)
• Motohide Nishi (Yamanouchi)
• Nobuaki Sakashita (Parexel)
• Kiyoteru Takenouchi (Dendrite)
• Kazue Tomita (Eli Lilly)
• Masahiro Yokokawa (Parexel)
• Yoshio Tsukada (Aventis)

9
Size of TF and Modeling Teams in JCG
46 (including team leader)
10
Expectations on CDISC in Japan

• Facilitate business processes among
  Investigators, Pharmaceutical companies, CROs,
  Clinical Laboratories, Technology vendors
• Increase efficiencies of performing clinical
  trials
• Facilitate reviews of regulatory submissions
• Provide means for long-term archive of electronic
  clinical trial data and digital signatures

• Support to utilize Foreign clinical data in Japan
• Support to provide Japanese clinical data to
  US/EU
• Fix the foundations for Multi-national/regional
  clinical trials including Japan

11
JCG Mission

• Support and facilitate CDISC implementation in
  Japan
• Contribute to the establishment of CDISC
  Standards included Japanese local requirements

12
Current Activity (till 2003)

• Introduction and Learning CDISC
• in Japan
• Education Membership
• PR/Communications
• Modeling Teams
• ODM (Operational Data Model)
• LAB (Laboratory Data Model)
• SDS (Submission Data Standards)
• ADaM (Analysis Data Model)

13
Future Activity (2004 onward)

• Support and facilitate CDISC Implementation in
  Japan
• Increase Awareness
• Share information in JCG
• Organize Training Courses
• Influence Regulatory Authority
• Facilitate CDISC Standards into daily business

14
JCG Past and Future
2002
2003
2004
2005 -
Introduction phase
Learning phase
Implementation phase
15
JCG Contacts

• Nobuaki Sakashita (Education Membership) cdiscjs
  aka_at_yahoo.co.jp
• Kiyoteru Takenouchi (PR/Coms)
• kiyoteru.takenouchi_at_dendrite.com
• Mineko Fujimoto (Modeling)
• mfujimoto_at_schering.co.jp
• Yoshio Tsukada
• cdiscjtsukada_at_yahoo.co.jp

16
Japan CDISC Group

• Think Globally
• Act Locally
• Thank you!