CDISC Implementation Strategies: Lessons Learned and Future Directions

This an intermediate topic targeted at an audience familiar with CDISC standards and eCTD submissions.

Lessons learned and future directions will be shared from three organizations implementing the CDISC standards.

Speakers from Genzyme Corporation, Octagon Research Solutions, and Vertex Pharmaceuticals will present the unique challenges, opportunities, and perspectives of each organization.

Each speaker will provide an overview of their CDISC strategy scope (SDTM, ADaM, LAB, CDASH, ODM) and implementation status. They will provide insight into use of the SDTM model as an operational and/or submission standard. The use and timing of SDTM trial design and Define.xml/pdf will be covered. Speakers will describe relationships between SDTM and ADaM datasets and statistical reporting programs. Presentations will contain overviews of business processes (internal and/or external), quality architectures (SOPs, WIs, templates), and technologies and tools used by each organization for CDISC. SDTM conversion estimates and metrics (quantity, time, resources, quality, and FDA acceptance) will be shared.