SCDM India Virtual Single Day Event

Society for Clinical Data Management (SCDM) > SCDM India Virtual Single Day Event

Welcome to The World of Virtual Clinical Trials- Entering a New Era of Design, Conduct, Monitoring and Analysis.

Our theme for the first virtual SDE is highly relevant during the COVID-19 scenario, when the whole world is struggling to manage through the pandemic.  Our industry is also suffering with 70%-80% of sites inaccessible or only having restricted or proscribed access for monitoring visits.  Many sites are also focused on COVID-19 care with less staff availability to help with ongoing studies and patients not able to travel to sites for study visit appointments.  Remote monitoring, at-home lab draws, telehealth visits, and the virtual trial platform are becoming more important these days as times are changing.  The impact of the pandemic may result in a change in the way we live in the future; therefore, understanding the capabilities, technology and opportunities on virtual possibilities of conducting clinical trials by ensuring the Design, Conduct, Monitoring and Analysis enables adapting to this paradigm. It thus is a great opportunity for all to be part of this SDE to broaden our knowledge as clinical research professionals.

AGENDA

Co-Chairs:

Deepu Joseph

VP and Global Head of DM
Quanticate

With over 15 years of experience in Clinical Data Management with large and small CROs, Deepu Joseph has successfully led small and large teams within Data Management globally to deliver on various therapeutic areas and phases of clinical trials for the top 10 Global Pharma clinical development requirements.  Has end to end data management exposure and understanding from Paper studies to various EDCs and has been successful in Capability Development, DM Offshoring, Functional Service Management, Operations Management and Optimization with strong metrics-oriented strategies to meet Quality and Timeline requirements.

Kripesh Krishnan

General Manager
Accenture

Kripesh has 16 years of experience in Pharma/Clinical research industry, which includes over 14 years in Clinical Data Management. He is a pharmacist by training; completed his Masters from JSS College of Pharmacy, Ooty and a certified Six Sigma Green Belt from Indian Statistical Institute, Bangalore

Kripesh is currently serving as General Manager in the Life Science R&D Operations in Accenture, Hyderabad. In his role as Site Lead, he is responsible for running the operations and Customer management. Earlier, Kripesh was with IQVIA (erstwhile Quintiles) in a leadership role where he managed and led several key accounts and was responsible for end to end delivery.

He is passionate about operations excellence and working with people. Participated and presented in various academic/industry forums.

Nagalakshmi Shetty

Vice President Operations
PRA Health Sciences

Nagalakshmi Shetty is VP Operations and India Country Head at PRA Heath Sciences. She comes with nearly 20 years of experience in areas including Operations Management, Team Setup, Business Performance Management, Strategic Management, Process Design & Excellence, Leading Cross Regional Initiatives and Automation Projects.

At PRA she has the responsibility of leading the build out of the Bangalore office and supporting the needs of PRAs various businesses. In her previous organization IQVIA, she was responsible for operations of Data Management Teams, comprising of those working with multiple customers & platforms and those dedicated to a customer. She has set-up teams from its inception, including a large DM FSP team and offshore operations for DM, Safety, Bios and Clinical for an acquisition.

Nagalakshmi is a KPMG Certified Six Sigma Black Belt, a Balanced Scorecard Professional and Certified in Business Analytics & Intelligence from IIMB. Most recently also certified in Managing Global Firms and Strategic Management from Wharton.

Keynote Speaker:

Michael Tucker

Senior mHealth Solutions Specialist
Medidata Solutions

Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials.  Over the last decade, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials.  His 30-year career in medical research includes 8 years with the US government conducting and supporting surgical research and 22 years working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research.  Michael has been a participant in two clinical trials, bringing a unique perspective to the use of clinical technologies.

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