Project | ScopeScope |
The 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 NMPA). 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 | (, Gilead | )aatiya.zaidi@gilead.com | |
| Amy Palmer | (CDISC)apalmer@cdisc.orgTBC | ||
| Bhavin Busa | (Vita Data Sciences), Independent | bhavinbusa@gmail.com | |
| Nicola Newton, PHUSE Project Assistant | )
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| Objectives & Deliverables | Timelines | |||||
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Publish responses to questions received under: | ||||||
| Ongoing | ||||||
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| Published Deliverables | Date |
| Integration Strategies in Support of ISS/ISE Submissions: Version 1.0 | 27-Oct-2020 |
| Best Practices for Submissions of Event Adjudication: Version 1.0 | 02-Dec-2019 |
| Project Members | Organisation |
| Kajal Tahiliani | Cytel |
| Kamiar Mike Hamidi | Merck |
| Kannan Nagureddi | Amgen |
| Kapila Patel | IQVIA |
| Katherine Xie | AbbVie |
| Kathy Knuckles | Eli Lilly |
| Keith Hibbetts | Eli Lilly |
| Kelly Mewes | Roche |
| Ken Stoltzfus | Accenture |
| Kristie Kooken | Achaogen |
| Kristin C Kelly | Pinnacle 21 |
| Kiran Bonda | Syneos Health |
| Kiran Kumar Kundarapu | Merck |
| KiranKumar Padhiar | Janssen Research & Development |
| Koichi Yamaguchi | Eli Lilly |
| Naveed Khaja | Industry |
| Olga Vovk | NIH |
| Pritesh Solanki | Merck |
| Ramachandran Radhakrishanan | Merck |
| Raman Bassi | Bayer |
| Remesh Kavicharla | CRC Pharma |
| Robert Stemplinger | Industry |
| Rui Li | FDA |
| Ruth Alonso | Chiltern |
| Sahil Jindal | ICON |
| Sairam Gorthi | Janssen Research & Development |
| Sameer Saxena | Bayer |
| Shivaram Nagabhushana Sharma | ICON DOCS |
| Shravan Kv | Data Foundry |
| Silke Hochstädter | AbbVie |
| Soumya Rajesh | Amgen |
| Sreekanth Reddy Yasa | IQVIA |
| Srinivasa Rao Mandava | Industry |
| Sterling Hardy | Bristol Myers Squibb |
| Ta Jen Chen | FDA |
| Tiffany Tian | Industry |
| Tina Gursahani | Industry |
| Trevor Mankus | Industry |
| Unnat Patel | Pfizer |
| Vanessa Sarrechia | Janssen Research & Development |
| Veena Nataraj | Shire |
| Veerie Coenen | Janssen Research & Development |
| Venkata Peri | Janssen Research & Development |
| Vishnu Kollisetti | PPDI |
| Wei Lin | FDA |
| Weiya Zhang | FDA |
| Wioletta Schulze | Grünenthal |
| Yan Lei | Janssen Research & Development |
| Yoshiko Kitagawa | Industry |
| Zhongwei Zhon | Pfizer | Winkle Lu | Industry