Project ScopeThe Standards Implementation Nuances sessions at the March North America 2016 CSS and June EU 2016 CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers. In addition, there were many questions discussed related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, China FDA). It became very clear that the Industry is in need of a forum and subsequent knowledge-base (FAQ) to address these challenges. This project team was formed in June 2016 to collaborate with Subject Matter Experts (SMEs) from the industry, CDISC, and the FDA. The goal of this project team is to:
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Project Leads | |
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Aatiya Zaidi | aatiya.zaidi@gilead.com |
Amy Palmer | |
Bhavin Busa | bbusa@vitadatasciences.com |
Wendy Dobson (PHUSE Project Manager) |
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Team continue to provide responses to questions received. They are also looking at how they can evolve |
Resources |
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Integration Strategies in Support of ISS/ISE Submissions: Version 1.0, 27-Oct-2020 Best Practices for Submissions of Event Adjudication: Version 1.0, 2-Dec-2019 |
Project Members | Company |
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Achim Klotz | Roche |
Aiming Yang | Merck |
Ajay Gupta | PPDI |
Amy Adyanthaya | Biogen |
Angelica HochJNJ | Janssen Research & Development |
Anne Lindberg | Roche |
Annette Travalent | Eli Lilly |
Arvind Sri Krishna Mani | Zifornd |
Audrey YuJNJ | Janssen Research & Development |
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 JonesITS JNJ | Janssen Research & Development |
Grace Feng | BMS |
Hans Peter - Schreiter | Entimo |
Harsha Anantanardhan | Pfizer |
Helena Sviglin | FDA |
Himaja Surapaneni | Chiltern |
IIse AugustynsJNJ | Janssen Research & Development |
Jack Zhang | FDA |
Jade Chen | FDA |
Janet Roich | Amgen |
Jee Run Lee | FDA |
Jeffry Florian | FDA |
Joanne Zhou | GSK |
Johannes Ulander | S-Cubedcubed |
John Bielinski | Independent |
Joosep Raudsik | Statfinn |
Julie MaynardJNJ | Janssen Research & Development |
Kajal Tahiliani | Cytel |
Kamiar Mike Hamidi | Merck |
Kannan Nagureddi | Amgen |
Kapila Patel | InventivHealth |
Katherine Xie | Abbvie |
Kathy Knuckles | Eli Lilly |
Keith Hibbetts | Eli Lilly |
Kelly Mewes | Roche |
Ken Stoltzfus | Accenture |
Kiran Bonda | Inventiv Health |
Kiran Kumar Kundarapu | Merck |
KiranKumar PadhiarJNJ | Janssen Research & Development |
Koichi Yamaguchi | Eli Lilly |
Kristie Kooken | Achaogen |
Kristin C Kelly | pinnacle Pinnacle 21 |
Project Members | Company | ||
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Lakshmi MallelaITS JNJ | Janssen Research & Development | ||
Laura Bellamy | PPDI | ||
Laura Schonwalder | Triangle Biostatistics | ||
Liekie Gijsbers | OCS Life Sciences | ||
Magdalena Wojciechowska | Roche | ||
Majdoub Haloui | Merck | ||
Marguerite KolbITS JNJ | Janssen Research & Development | ||
Marjorie Nowak | Novartis | ||
Marleen NijsITS JNJ | Janssen Research & Development | ||
Mathias Lebreton | Novartis | ||
Nancy Brucken | CSG | ||
Natalia Jacquet | PhastarPHASTAR | ||
Nate Freimark | The Griesser Group | ||
Naveed Khaja | Independent | ||
Olga Vovk | NIH | ||
Peter Van Reusel | CDISC | ||
Pritesh Solanki | Merck | ||
Rabia Ahmad | GSK | ||
Ramachandran Radhakrishanan | Merck | ||
Raman Bassi | Bayer | ||
Remesh Kavicharla | CRC Pharma | ||
Robert Stemplinger | Industry | ||
Rui Li | FDA | ||
Ruth Alonso | Chiltern | ||
Sairam GorthiJNJ | Janssen Research & Development | ||
Sameer Saxena | Bayer | ||
Shravan Kv | datafoundry | Shravan KV | Data Foundry |
Silke Hochstädter | Abbie | ||
Soumya Rajesh | Amgen | ||
Srinivasa Pillarisetty | Astrazeneca | ||
Srinivasa Rao Mandava | Industry | ||
Sterling Hardy | BMS | ||
Ta Jen Chen | FDA | ||
Tiffany Tian | Industry | ||
Tina Gursahani | Industry | ||
Trevor Mankus | Industry | ||
Unnat Patel | Pfizer | ||
Vanessa SarrechiaJNJ | Janssen Research & Development | ||
Veena Nataraj | Shire | ||
Veerie CoenenITS JNJ | Janssen Research & Development | ||
Venkata PeriJNJ | Janssen Research & Development | ||
Vishnu Kollisetti | PPDI | ||
Wei Lin | FDA | ||
Weiya Zhang | FDA | ||
Wioletta SchulzeGrunenthal | Grünenthal | ||
Yan LeiITS JNJ | Janssen Research & Development | ||
Yoshiko Kitagawa | Industry | ||
Zhongwei Zhon | Pfizer |