The maturing of clinical data standards like those of CDISC, the Clinical Data Interchange Standards Consortium, is setting the stage for proactive data management in trials--a strategy gaining traction. Managing data ahead of the curve puts drug developers in a better position to make timely trial decisions while keeping regulatory matters on track.
It also helps investigators remain inspection-ready. With CDISC comes additional regulatory pressure in the form of data quality expectations. "Data management used to be an afterthought," said Susan Bornstein, EVP at eClinical Solutions, in a phone interview. The trial data service provider is "working toward CDISC, as are our partners," she said.
Her drug-sponsor customers, both large and small companies, need help with CDISC implementations, she said. Defining standard operating procedures, establishing governance and developing change management processes are all areas that require standards knowledge as well as a broader skill set.
In its 2010 goal setting, CDISC says it is targeting alignment with the goals of the FDA's drug and biologics centers. CDISC is also pushing this year for greater adoption of its standards early in the research process, at the study design stage. This push is a counterpoint to the existing implementations of the submission data standards, in an attempt to get both these adopters and newcomers to use the standards-based techniques throughout the development process, rather than just at the submissions stage.
- here's the CDISC announcement of 2010 plans