Program Overview

TBD Oral Presentation   Co-Chairs for the Annual Conference 
TBD Panel Discussion   Anitha K
TBD Story Telling / Ignite Sessions   Deven Babre 
      Dr. Deepak Kallubundi
Evolution of Clinical Data Science - Data | Technology | Analytics
With developments happening in clinical research area there is an uptick in the data which is complex, huge and there is variety of data. Industry is adopting variety of technologies and are using data analytics for making informed decisions for this to happen these are three enablers for this evolution within Clinical Data Science
Leadership Forum –3rd Dec 2020
17:30 - 19:30 LEADERSHIP FORUM Identification and Engaging Outsourcing of Services in Life Science
1.Leadership Talk 1 Is Acceleration in Digital Transformation within Healthcare Industry a New Normal – Case Studies & Adoption Strategies
2.Panel Discussion  Understanding Data Democratization in Clinical Research Landscape - Advantages, Challenges & Way Forward 
3.Leadership Talk 2  Future of Decentralized Clinical Trials in New normal.
Day 1 – 4th Dec 2020
7:30 - 10:00 Leap from traditional Data Management to Data Science
Understanding guiding principles related to Data Science. Tips and Tricks to implement concepts such as Metadata consolidation (PRM to eCTD), Visualization considering ICH E6 R2 framework a practical insight
9:30 - 10:00 BREAK (Quick Entertainer) TBD
10:00 - 10:30 Inauguration & Welcome Session
10:30 - 11:15 Keynote Talk - 1 - Digital Disruption / Transformation in Life Sciences
11:15 – 11:30 BREAK
11:30 - 13:00  Track 1 – Metrics / KPIs used in CDM to Track & Monitor Progress of Study / Program
Track 2 – Evolution of Monitoring Approach (2.0) Track 3 – SDTM & CDASH- Do we need both data standards?

Session 1 Session 1 Session 1
13:00 - 13:45 LUCH BREAK
13:45 - 15:15 Track 1 – Technology & Big Data Impacting Clinical Development during New normal Track 2 – Embracing Risk-Based Monitoring during New Normal
Track 3 –  “Humans” + “Machines” = Intelligence with Speed: DM Case Studies"
Session 2 Session 2 Session 2
15:15 - 16:00 Keynote Talk -2 - Technology Adoption in New Normal for Conducting Clinical Trials 
16:00 - 16:15 BREAK
16:15 - 17:30 Clinical Data Management in 2030 - What does it look like & how different the role of Data Manager would be ?  
Quizzes – Winners & Goodies or Vouchers; Standup Comedy; Inspiration Speech (Mix & Match Across the program)
Day 2 – 5th Dec 2020
10:00 - 10:45 Keynote Talk -3 - Key Challenges in Data Science space for Vaccines
10:45 – 11:15 Academic Session - Understanding Analysis of RWD
11:15 - 11:30 BREAK
11:30 - 13:00  Track 1 -  Balance in Technology vs Human, Are we there? – Data Science
Track 2 – eSource- Current State vs Future State.

Track 3 – RWE/RWD Is It Beginning To Pay Off


Session 3 Session 3 Session 3
13:00 – 13:45 LUNCH BREAK
13:45 - 14:30 Keynote Talk - 4 - New normal related to Data Science Data Science – what it is (not). Data Science ThoughtSphere.
Evolution of Data Science in New Normal
14:30 - 16:00 Track 1 –  Complex Endpoints for Decentralized Trials - Data Science Track 2 – Are We Adequately Addressing Risks and Quality Compliance?  Track 3 – ML/AI- Challenges and opportunities in  implementing analytics in Clinical Trials
Session 4 Session 4 Session 4
16:00 - 16:15 BREAK
16:15 - 17:15 Regulatory Talk
Topic 1 - Regulations how do they Guide and Embrace DDM (Digital Disruption  Mutation) - Regulators Lens
Topic 2 - QbD and Quality Risk Management Framework through Regulators Lens
17:15 - 17:30 Vote of thanks



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