Boston, MA

Thursday 13 August 2020

Navigating the World of Clinical Data Standards & Submission



Era of Mandatory eData Submission to the PMDA! Hands on Our Experience and Learning – Mayumi Kominami, Novartis

Preparing Legacy Data for a Submission: PMDA and FDA Standards – Ajay Yalwar, Pradnya Bharambe & Jennifer McGrogan, Covance

Embracing CDISC’s “Guidance for Ongoing Studies Disrupted by COVID-19” – Bhargav Koduru, Sarepta Therapeutics

Important Considerations for Submission Metadata (Define-XML) Implementation – Prafulla Girase & Varia Cartledge, Alexion

A Programmer’s Journey Through the BIMO Submission Process – Raghavender Ranga & Olga Barboy, Vertex

Automation of TFL Generation Using CDISC 360 Enriched Standards – Bhavin Busa, Vita Data Sciences & Prasanna Murugesan, AstraZeneca
To follow.

TidyCDISC: An Open-source Application to Interactively Create Tables, Figures, and Patient Profiles from ADaM Data – Maya Gans, Cytel & Nate Mockler, Biogen

Listen to the virtual sde here


SDE Chairs:

Greg Ridge, Alexion

Lavanya Peddibhotla, Covance








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