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Virtual

Nov 04, 2021 9:50 AM - Nov 05, 2021 5:00 PM

(US Eastern Standard Time)

Master Protocols and Complex Innovative Design

Innovating for Modernized Clinical Trials

Session 5: Challenges and Recommendations for Remote Data Collection Through Telemedicine and Digital Health Tools

Session Chair(s)

Fanni  Natanegara, PhD

Fanni Natanegara, PhD

Sr. Director, Global Statistical Sciences - Japan

Eli Lilly and Company, Japan

Rui (Sammi)  Tang

Rui (Sammi) Tang

Vice President, Global Head of Biometrics

Servier Pharmaceuticals, United States

The digital revolution has transformed many areas of our life including pharmaceutical drug development to enhance efficiency and optimize value in clinical trials. The session is meant to draw more attention in the face of the coronavirus disease 2019 (COVID-19) outbreak, which has caused unprecedented disruption in the conduct of clinical trials and presented considerable challenges and opportunities for clinical trialists and data analysts. Speakers will present opportunities with virtual, remote, digital, or decentralized clinical trials as viable options to enhance efficiency in drug development and, more importantly, in offering diverse patients easier and attractive means to participate in clinical trials. Case studies will be shared to highlight benefit and challenges in using digital data and telemedicine to clinical trials including data acquisition, processing, and analysis in a virtual trial setting. Issues of patient safety, measurement validity, and data integrity will be reviewed, and considerations are put forth with reference to the mitigation of underlying regulatory and operational barriers.

Speaker(s)

Venkat  Sethuraman, PhD, MBA, MS

Best Practices for Decentralized Clinical Trials - Statistical and Data Considerations

Venkat Sethuraman, PhD, MBA, MS

Bristol Myers Squibb, United States

Senior Vice President, Global Biometrics and Data Sciences

Mercedeh  Ghadessi, MS, MSc

Speaker

Mercedeh Ghadessi, MS, MSc

Bayer, United States

Principal Statistician in Biomarker and Data Insight

Linda N Simba, MBA

Speaker

Linda N Simba, MBA

Lilly, United States

Advisor - Clinical Systems, Processes & Information

Anindita  Saha

Speaker

Anindita Saha

FDA, United States

Associate Director Strategic Initiatives, Digital Health Center of Excellence

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