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by J. Brega
The Bay Area CDISC Implementation Network is the first regional CDISC implementation group, founded in March of 2005. We have held six meetings so far, with attendance ranging from 35 at the first one to 80 at the most recent. Ourgoal is to meet about every 6 weeks. The 170 active participants represent 47 companies, including 21 small pharmaceutical companies, 7 medium and large ones, 17 vendors, a medical device company and a large health care provider. About 45 members hold management positions in pharmaceutical companies. Our announcements also go outto representatives of the other regional organizations and the management of CDISC.
It became apparent early on that the greatest need of the participating companies is education, and this was confirmedby a poll of our advisory group in August. Our programs have included presentations and a panel discussion by representatives of companies who are currently implementing, a tutorial seminar on SDTM given by Jane Diefenbach, and a tutorial seminar on the ODM given by Dave Iberson-Hurst, with implementation case studies by James Demmitt(Ninanza) and Robert Barr (DataLabs). We are thankful to all our presenters, who have volunteered their time and knowledge, and to the companies who have hosted the meetings at their own effort and expense.
We expect the charter of the Network to evolve as more local companies undertake implementation projects. A goal for 2006 is to establish a more interactive round table forum for the people involved in these projects to share issues and solutions.
Past presentations and meeting notes can be downloaded from our website at www.BayAreaCDISC.org.
To receive our announcements please e-mail a request to John Brega at JBrega@PharmaStat.com.
by S. Kenny
The RTP CDISC Users Network was organized in mid 2005 and currently has approximately 80 people registered with the User Network listserv. The mission of this network is to increase the familiarity about CDISC, provide a forum for members to discuss implementation issues, and provide a mechanism by which local pharmaceutical industry professionals can interact with the larger CDISC community. The user network plans to meet at least 5 times a year and the format will include active panel discussions, open working sessions, demonstrations, and presentations. The network is free and welcomes all interested parties. To learn more about the RTP CDISC User Network and to sign up to receive announcements, please visit http://groups.yahoo.com/group/rtp_cdisc.
The RTP CDISC User Network held two meetings in 2005. The first kick-off meeting was attended by 50 people. For this meeting, there was an overview of the CDISC teams and basic principles provided by Susan Kenny (SAS) and Susan Duke (GSK), followed by two presentations, given by Susan Kenny and Jack Shostak (Duke Clinical Research Institute), which focused on implementation issues for SDTM and ADaM. In an open forum, all participants shared where their companies were with respect to CDISC implementation.
For the second User Network meeting, the network was fortunate to have a visit from Becky Kush (CDISC) and she provided a vision for the future of CDISC and industry standards in general. Other presentations included an in-depth review of ADaM standards by Cathy Barrows (GSK) and a presentation by Chris Decker (SAS) to describe an EDC implementation of ODM in a compliant environment.
The first meeting of this year will be on 10 February 2006 where presentations and round-table discussions regarding SDTM implementation issues will be lead by Randall Austin (GSK), Frank DiIorio (Rho), and Jeff Abolofia (Rho) followed by a demonstration of WebSDM given by Sally Cassells (Lincoln Technologies)
by W. Kubick
The Midwest user’s group held its inaugural meeting on 28 November 2005. The meeting was hosted by Chris Young of Astellas, and included about 12 representatives from Chicago area companies including Astellas, Abbott, Baxter, Lincoln Technologies, TAP and Takeda. Much of the initial interest is centered around the CDISC SDTM, but future topics will examine other CDISC standards and activities. A second meeting is scheduled for 13 February 2006, and will include representatives from Proctor & Gamble and 3M Pharmaceuticals.
by D. Godoy
The Delaware Valley Users Group has had two teleconference meetings so far. The first one was our kickoff meeting, during which we introduced the Network to those in attendance, defining our meeting frequency for the remaining of the year, and created a small group to develop its Bylaws. The second meeting included a review of the first draft of the Bylaws, as well as a guest speaker, Sally Cassells (Lincoln Technologies & Team lead for the CDISC ODM Team) who gave an very nice overview of the ODM Team and the "Define.XML". Since our last call, we have created an Executive Committee, whose members are: Dan Godoy (Chair, AstraZeneca), Gail Stoner (Centocor), Gary Cunningham (AstraZeneca), Musa Nsereko (Cephalon), Barry Cohen (Octagon Research Solutions), Michele Thomas (GSK), Robert S. Schechter (AstraZeneca), and Mary Varughese (Merck Co.); This committee was tasked with and finalized the User Network's Bylaws
by M. Palmer
Cindy Tong and Jennifer Ly of PPD discussed "CDISC in Practice" with some two dozen other CDISC users at the fourth face-to-face meeting of the NJ-NY-PA CDISC users network on 19 January 2006. Thanks to Bristol-Myers Squibb for hosting the meeting at their Hopewell, New Jersey facility. Cindy and Jennifer presented their experiences and lessons learned from the implementation of CDISC's standards in a major clinical trials project at PPD. Cindy's and Jennifer's PowerPoint is posted on the NJ-NY-PA networks web site http://groups.yahoo.com/group/NJNYPA_CDISC_UN. Don't miss the picture of the delighted meeting participants!
In break-out groups following the presentation, participants shared their CDISC implementation expectations and experiences in light of Cindy's and Jennifer's talk. We discovered that each participating company that has implemented CDISC has its own unique legacy, technology, and business needs and, therefore, no single CDISC implementation strategy can be recommended across the board. Regularly scheduled face-to-face meetings are held every other month. Email Michael Palmer (mcpalmer@zbi.net) to be added to the NJ-NY-PA CDISC users network email list.
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A demonstration of excellence in communication is visible as user groups have been keeping in touch with each other and prepare for a Face to Face meeting of their leaders in June 2006. This will further solidify plans to ensure better communication across the Networks and integration with CDISC initiatives. CDISC is also working to increase support for these Networks to ensure alignment with the CDISC principles and strategy. |
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