Effective use of CDISC Therapeutic Area Data Standards in the study setup

The Clinical Data Interchange Standards Consortium (CDISC) has, in recent years, released several Therapeutic Area User Guides (TAUGs) ranging from Alzheimer Disease (AD) to Virology. The TAUGs have been developed via collaboration between different standards development organizations with assistance from the industry all to improve the process of collecting, comparing, analyzing and reporting regulatory data about therapeutic areas.

As of December 2016, the CDISC standard format will be the only format for submitting clinical trial data in the U.S. so we are all well aware of the importance of CDISC compliance. But when it comes to TAUGs, how ready are you to apply these recently developed standards to your development processes?

Implementing data standards is good practice and TAUGs lay out guidance for all involved parties on how to collect, analyze and report data appropriately. But the standards compliance is complex and requires in-depth knowledge of both processes and standards in clinical research. It requires expert people and technology to support the development and management of standards for a successful submission.

intilaris has been at the forefront of implementing and integrating of standards management within large organizations to facilitate the application of an increasing volume of industry standards. intilaris Clinical Standards Service enables standards management encompassing:

  • Implementation of applicable TAUGs as well as global company standards
  • Standard driven clinical development by employing standards at the earliest stages of study planning through to the submission process
  • End-to-end standards traceability
  • Automation of study metadata setup
  • Instant impact analysis of all changes

We guide customers in evaluating and implementing top market standards management technology for effective and standardized clinical study planning and setup.