Initiative Overview

Rationale

Vision

In collaboration with the FDA through a public-private partnership, the SEND Implementation for Cross-Study Analysis Initiative is pursuing the development of proposed solutions for the implementation and use of CDISC SEND data packages with the aim of facilitating cross-study analysis. Open-source guidance on SEND as applied to study analysis, intended for use by CROs, regulators, and sponsors, has the potential to contribute to a broader knowledge base across early-stage R&D and support faster, more improved decision-making.

Unmet Needs

The CDISC SEND format is growing in adoption across the industry, but variability in its use/implementation, prevents meaningful and accessible single-study analysis as well as cross-study analysis on a broader scale, limiting the potential value of SEND. An examination of SEND implementation variabilities, as well as existing challenges in the use of SEND data packages for analysis, is needed to enable meaningful analysis use cases.

Benefits

With consistent SEND study data packages, Organizations can:

  • More easily compare data generated across multiple studies, leading to more informed decision making to bring better compounds to patients faster
  • Generate more efficient processes to deliver data leading to decreased cycle times for both CROs and Sponsors
  • Reduce the need for sponsors and CROs to develop and maintain internal SEND standards,
  • Improve the quality of data sets and reduce errors to streamline Regulatory review and analysis

Learn About Our Progress

As we pursue the development of proposed solutions for the implementation and use of CDISC SEND data packages with the aim of facilitating study analysis, we plan to share our progress through various public channels like manuscripts, Congress presentations and forums as well as webinars and workshops. We invite you to read about our development work below and get information about upcoming events and progress by joining our mailing list .

Additional Resources

Click to read poster abstract. 

Should you have any questions about the projects or upcoming events, please email us at info@biocelerate.org.