CDISC Europe Interchange is a virtual event that provides opportunity for attendees to network and gain information about best practices in clinical data standards implementation and the associated value. The 2021 iteration will focus on key industry themes including Analysis Data Model (ADaM), Real World Data, COVID-19 impact on CDSIC compliance, Tech-enabled Standards, Global Submissions and CDISC 360 among other industry-mapped topics.
Session 1: Implementation of a Metadata Registry (MDR)
Clinical standard initiatives and regulations have driven the need for defining standards across all functions of clinical trial activities. To create a holistic solution that allows governance teams to effectively track standards and also aid study teams during setup, conduct and analysis, one must consider the creation of metadata repository along with all necessary functionalities.
Andrea Rauch - GPO Clinical Data Standards, Boehringer Ingelheim
Mayank Bhatia, Head, ADD Data Standardization and Biometrics, TCS
Charusheela Thakur, Domain Consultant, ADD Data Standardization and Biometrics, TCS
Session 2: Accelerating SDTM Generation with AI/ML
The CDISC Study Data Tabulation Model (SDTM) is a mandatory standard for regulatory submissions of clinical trial data. As the study designs are getting intricate, it adds complexity and variance to the case report forms (CRFs) and third-party data. Generation of SDTM datasets is time consuming and resource-expensive.
- Prasoon Sangwan - Product Manager, TCS
- Mayank Bhatia, Head, ADD Data Standardization and Biometrics, TCS
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