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Standard implementation nuances exist across the multiple available versions of SDTM and ADaM. The project will establish a framework for the collection, compilation, assessment, response to, and publishing of common SDTM and ADaM implementation challenges/nuances. This is important for sponsors who are still transitioning to newer versions of standards (eg SDTM), as well as the vast majority who have to govern multiple versions, even for a single product or application. This is a join project between PHUSE and CDISC. |
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Project Leads |
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Aatiya Zaidi | Aatiya.Zaidi@gilead.com |
Amy Palmer | |
Bhavin Busa |
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Aatiya Zaidi - aatiya.zaidi@gilead.com
Amy Palmer - apalmer@cdisc.org
Wendy Dobson (PHUSE Project Manager) |
Project Members | Company |
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Achim Klotz | Roche |
Aiming Yang | Merck |
Ajay Gupta | PPDI |
Amy Adyanthaya | Biogen |
Angelica Hoch | JNJ |
Anne Lindberg | Roche |
Annette Travalent | Lilly |
Arvind Sri Krishna Mani | Zifornd |
Audrey Yu | JNJ |
Brian Harris | Medimmune |
Colleen Ratliffe | FDA |
Cristina Do Carmo | Novartis |
Cynthia Stroupe | UCB |
Diane Wold | CDISC |
Dorothy Dlamini | Bayer |
Doug Warfield | FDA |
Elizabeth Langevin | Takeda |
Farhan Hameed (CJ) | Pfizer |
Gloria Jones | ITS JNJ |
Grace Feng | BMS |
Hans Peter - Schreiter | Entimo |
Harsha Anantanardhan | Pfizer |
Helena Sviglin | FDA |
Himaja Surapaneni | Chiltern |
IIse Augustyns | JNJ |
Jack Zhang | FDA |
Jade Chen | FDA |
Janet Roich | Amgen |
Jee Run Lee | FDA |
Jeffry Florian | FDA |
Joanne Zhou | GSK |
Johannes Ulander | S-Cubed |
John Bielinski | Independent |
Joosep Raudsik | Statfinn |
Julie Maynard | JNJ |
Kajal Tahiliani | Cytel |
Kamiar Mike Hamidi | Merck |
Kannan Nagureddi | Amgen |
Kapila Patel | InventivHealth |
Katherine Xie | Abbvie |
Kathy Knuckles | Lilly |
Keith Hibbetts | Lilly |
Kelly Mewes | Roche |
Ken Stoltzfus | Accenture |
Kiran Bonda | Inventiv Health |
Kiran Kumar Kundarapu | Merck |
KiranKumar Padhiar | JNJ |
Koichi Yamaguchi | Lilly |
Kristie Kooken | Achaogen |
Kristin C Kelly | pinnacle 21 |