CDISC: The Road Ahead

This week’s guest blog post comes to use from David Handelsman, Life Sciences Business Solutions Manager at SAS. You can read more about David here.

With the annual CDISC International Interchange conference beginning this week, I’m reminded of how far the life sciences industries have come in embracing and adopting standards. CDISC – the Clinical Data Interchange Standards Consortium – includes members from more than 200 industry companies, all supporting the notion that – across an industry – data standards are an important necessity.   Long gone are the days when businesses questioned the value of company standards, and across the life sciences industries the value of cross-company standards are no longer questioned. The discussion has fundamentally moved from “what” to “why” to “how”, and now “when”. As will no doubt be discussed at length during the Interchange, there are now a wealth of examples that describe how to apply the CDISC standards to the business of clinical research data management.

When you think about, it’s actually quite extraordinary.   Companies have volunteered their staff to contribute to this effort, knowing the benefit helps their competitors as much as it helps themselves.   As is often said, a rising tide does lift all boats. Data capture (CDASH) standards have just been approved; data submission (SDTM) standards have been approved for some time. And analysis standards (ADaM) are in progress.   With these data standards in place, the transition between associated business processes should become, to overuse the phrase, standard as well.

Has industry reached the end of this journey successfully? Of course not.   But we’ve done well along several segments of the trip.    As we’ve moved from ‘what’ to ‘when’, the next question we need to be asking is ‘what next?’.