Project Scope Across industry, there are a wide variety of quality control (QC) checks for SEND datasets. This is currently done without commonly acknowledged scope and intensity, based on the companies own approaches. For more confidentiality of the quality of SEND dataset across different stakeholders this group targets to:
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Project Leads | |
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Jesse Anderson | |
Michael Rosentreter | |
Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
Objectives and Deliverables | Timelines |
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Establish definitions for QC procedures | Q2 2021 |
Establish consolidated list of recommended QC checks based on those definitions, subgroup feedback, and FDA feedback | Q2 2021 |
CURRENT STATUS Q12021 |
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Team received feedback from the FDA, sub team proposed definitions to work with QC of SEND datasets to discuss further during Q2 2021. |
Project Members | Organisation |
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Alejandro Mankin | FDA |
Arianne Motter | FDA |
Brett Coupland | AstraZeneca |
Cassandra O’Malley | PDS Life Sciences |
Diane Boram | GSK |
Eduardo Mundo | Nektar |
Erin Tibbs-Slone | Charles River |
Haley Wulff | BASi |
Isaac Mativo | PointCross |
Jamie Gilliam | Instem |
Janessa Piers | Merck |
Jennifer Feldmann | FDA |
Karen Porter | PointCross |
Karuna Polavarapu | PointCross |
Kathryn Brown | Sanofi |
Project Members | Organisation |
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Kurien Abraham | PointCross |
Laura Kaufman | PointCross |
Lindsy Eickhoff | Inotiv |
Mandie Rhodes | BMS |
Matt Bendekovits | Merck |
Matt Hayes | Gene |
Patty Brundage | FDA |
Peyton Myers | FDA |
Phil Drew | PDS Life Sciences |
Rick Thompson | Janssen Research & Development |
Senthil Palani | Xybion |
Sonja Geuens | Janssen Research & Development |
Soujanya Konda | IQVIA |
Stefano Gaudio | Roche |
Steve Polly | GSK |
Susie Antvorskov | Data Standards Decisions |
Yue Liu | Covance |