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Feb 19, 2021 10:00 AM - Feb 19, 2021 11:00 AM

Online

DIA DIRECT: The New Norm: Remote Monitoring of Sites and Patients

The adoption of remote monitoring requires virtual access to sites, data, and patients. What should sponsors assess before making the switch to a fully remote model?

Presenters

Nimita  Limaye, PhD

Nimita Limaye, PhD

Research Vice President, Life Sciences R&D Strategy and Technology, IDC, United States

Dr. Nimita Limaye leads R&D Strategy and Technology at IDC Health Insights, providing research-based advisory and consulting services on the Life Sciences industry. She represents Healthcare and life science on IDC's AI Council. She is an executive business leader with more than two decades of life sciences leadership experience in the pharma/CRO/tech consulting industry. She focuses on the role of data and technology in transforming drug development, RWD, synthetic data and analyzing and predicting evolving trends in the life sciences industry. Nimita was the chair of the SCDM board, chaired several conferences roundtables, given keynote talks, participated in fireside chats, and authored close to a 100 thought leadership papers.

Andrea  Bastek

Andrea Bastek

Director of Innovation, Florence Healthcare, United States

Andrea leads innovation at Florence, identifying the biggest challenges in clinical trial operations and harnessing technology to solve them. Prior to Florence, Andrea worked in leadership roles across the life sciences industry, including Abbott and St. Jude Medical.

Andreas  Beust

Andreas Beust

Head, Biostatistics, GCP-Service International, Germany

Andreas Beust is the Head of the Biostatistics team at the CRO GCP-Service International, which he joined in 2017. In his role as a statistician, he participated in more than three dozen clinical trials of medicinal products (Phase I through III) and medical devices (pre- and post-marketing). Additionally, Andreas obtained some experience as data manager and project manager. This shaped his perspective on how monitoring is approached and fueled the desire to combine centralized statistical analysis of trial data with improvement of data quality and monitoring processes.

Ioannis  Chatziioannidis

Ioannis Chatziioannidis

Owner and CEO, EOS Consulting, Greece

After 25 years in the Hellenic Air Force and NATO, Ioannis Chatziioannidis served as the Information Security Advisor in a multinational CRO with focus on data security of clinical trials. Ioannis has certified more than 115 companies across the globe, performing audits for ISO:27001 (Information Security), ISO:9001 (Quality Management), ISO:20000 (Service Management), and ISO:22301 (Business Continuity). He was the consultant on more than 55 GDPR Compliance projects and implemented various Management Systems, focusing on information security. Ioannis has recently been appointed by a US-based NPO-Beneficiary Organization as their Europe-wide Data Protection Officer (DPO), performing international research specialized in psychiatric trauma.

Lauren Sine Litzinger

Lauren Sine Litzinger

Process, Standards & Signal Interpretation Group Lead, Global Site & Study Ops, Pfizer, United States

Lauren Litzinger is the Standards Team Lead and Site Monitoring Business Process Owner within Global Site and Study Operations at Pfizer. Global Site and Study Operations drives study and site operational activities, including study management and site monitoring. Lauren has worked for Pfizer for over 20 years, starting as a Site Monitor and changing roles within the operational line to her current role, driving process consistency and implementation.

Susanna  Sellmann

Susanna Sellmann

Program Director, Cancer Clinical Research Unit, Princess Margaret Cancer Program, Canada

A medical radiation therapist by training, Susanna transitioned to oncology clinical research in the late 90s, then shifted gears to research administration in the early 2000s. Susanna’s roles have included organizing and running trial data management, institutional clinical trial regulatory compliance, and implementing a program-wide quality assurance and audit program. As program director, Susanna is actively involved in the day-to-day operations of the Cancer Clinical Research Unit, program development, and strategic planning. In 2006, Susanna established the Toronto SOCRA chapter to facilitate certified clinical research professionals’ access to continuing education credit. She has since become a board member and the President of SOCRA.

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