Project ScopeThe increasing interest/pressure to include results based on real world data as part of regulated Clinical Trial Submissions and similar research initiatives is testing how current regulatory and good practice requirements can incorporate these results into submissions. Whilst specific projects have successfully addressed these issues, RWE guidelines or points for consideration are not yet formalised. This project aims to focus on the issues within Real World Evidence and develop a White Paper which establishes a range of areas that need to be considered/impact the use of RWE in support of regulated clinical trial submissions |
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Project Members | Company |
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Adam Reich | IQVIA |
Andy Steen | EDJAnalytics |
Anil Sekhari | Sekharico Informatics |
Aldir Medeiros Filho | Industry |
Berber Snoeijer | Clinline |
Bhanu Kannan | FDA |
CHARAN KUMAR | Ephicacy |
Claudi Jimenez | Syneos Health |
Corey Young | EDJAnalytics |
Diego Saldana | Roche |
Elizabeth Merrall | S-Cubed |
Hao Chen | Pfizer |
Jeff Abolafia | Pinnacle21 |
Jingwen Zhang | Industry |
Kiichiro Toyoizumi | Shionogi |
Lisa Kang | Pharma Essentia |
Lisa Lin | FDA |
Marko Zivkovic | Genesis |
Michael Martinec | Roche |
Project Members | Company |
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Nicole Thorne | JNJ |
Nurcan Coskun | Industry |
Oluseun Shittu | GlaxoSmithKline |
Paul Murray | SAS |
Pranab Mitra | Merck |
Rachel Bowman | Loxley Analytics |
Rosa Bianca Gallo | The Hyve |
Scott Bahlavooni | Industry |
Siddharth Arthi | Zifornd |
Susan Eaton | Biogen |
Susan Olson | EDJAnalytics |
Susheel Arkala | MMS Holdings |
Shaojun Song | Yitu Technology |
Trisha Simpson | UCB |
Yixun Wu | Syneoshealth |
Ingeborg Holt | IMB |
Sadchla Mascary | Pfizer |
Swapna Kaveti | Industry |