Boston, MA

Thursday, 13 August 2020


Due to the latest developments of COVID-19, the PHUSE Boston SDE will be a
virtual event and open to all.

Register now



Navigating the World of Clinical Data Standards & Submission



Providing data in a standardised format (i.e. standards such as SDTM, ADaM, Define-XML, etc.) helps regulatory agencies receive, process, review and archive submissions more efficiently and effectively. From the sponsor perspective, these standards enable efficiency and automation, and maximise the value of the data. In an ideal scenario, organisations would look at standards implementation from all perspectives while developing and implementing their data standards strategy. Implementing standards can be a challenging task for multiple reasons. Some of these include constantly evolving data standards, regulatory differences, dearth of end-to-end technology solutions, organisational resources/operating models, etc. The PHUSE Boston SDE 2020 provides a great opportunity to learn how various organisations adapt to this challenging world of clinical data standards and submission.




Utilise the PHUSE App to connect with other attendees, view the speaker profiles and learn more about the event sponsors.

Sponsored by:



Time Presentation Speaker(s)
08:45–09:00 Attendees join webinar
09:00–09:15 Welcome Greg Ridge, Alexion
Lavanya Peddibhotla, Covance
09:15–09:50 Era of Mandatory eData Submission to the PMDA! Hands on Our Experience and Learning Mayumi Kominami,
09:50–10:25 Preparing Legacy Data for a Submission: PMDA and FDA Standards Ajay Yalwar, Pradnya Bharambe & Jennifer McGrogan,
10:25–10:45 Networking Break
10:45–11:00 PHUSE Updates Chris Hurley,
PHUSE Americas Director
11:00–11:30 Embracing CDISC’s “Guidance for Ongoing Studies Disrupted by COVID-19” Bhargav Koduru,
Sarepta Therapeutics
11:30–12:00 Important Considerations for Submission Metadata (Define-XML) Implementation Prafulla Girase & Varia Cartledge,
12:00–12:30 Lunch Break
12:30–13:00 A Programmer’s Journey Through the BIMO Submission Process Raghavender Ranga & Olga Barboy,
13:00–13:30 Automation of TFL Generation Using CDISC 360 Enriched Standards Bhavin Busa, Vita Data Sciences
Prasanna Murugesan, AstraZeneca
13:30–14:00 TidyCDISC: An Open-source Application to Interactively Create Tables, Figures, and Patient Profiles from ADaM Data Maya Gans, Cytel
Nate Mockler, Biogen
14:00–14:05 Closing Remarks Greg Ridge, Alexion
Lavanya Peddibhotla, Covance


SDE Chairs:

Greg Ridge, Alexion

Lavanya Peddibhotla, Covance

If you have any questions, or require any information, please contact the SDE Chairs.









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