CDISC, or it’s the most wonderful time of the year!
It’s that time of the year again!
A time of giving. A time to reflect on our many blessings. A time to offer a smile and extend a hand of friendship to our neighbors. And, yes, it’s even a time for Christmas carols, such as this classic tune from Andy Williams.
It is indeed the most wonderful time of the year!
Seriously, do not eat the red berries.
And if you’re involved in clinical trials, there is a special reason to celebrate this year: CDISC! CDISC is the organization responsible for developing and supporting standards for clinical trials, and 2016 represents some major milestones. First, as of Oct. 1, the Japanese Ministry of Health, Labour and Welfare requires drug makers to submit electronic data in CDISC standard format to the Pharmaceuticals and Medical Device Agency (PMDA) within Japan. Second, for studies starting after Dec. 17, submissions to the US Food and Drug Administration will now require CDISC standards.
Why are data standards important?
Standards make the review process more efficient so that new medications can reach patients quicker. Standards improve communication and processes within and across companies saving valuable resources. Standards make it easier to combine data of similar drugs from multiple sponsors to detect safety signals earlier. This article (now almost five years old!) provides more information on the importance of data standards in pharmaceutical development.
With all of these requirements for CDISC, what’s an analyst to do?
Well, I’d be remiss if I didn’t highlight JMP Clinical, the only software package leveraging CDISC standards making it accessible out-of-the-box. JMP Clinical has something for everyone on the development team: customizable patient profiles and adverse event narratives, analyses for safety signal detection, analyses to assess data integrity, and more.
How can JMP Clinical help your company? You can view an on-demand seminar explaining how the data-driven analytics of JMP and JMP Clinical can improve medical product development.
Last, but not least, congratulations to Chris Holland and Jack Shostak for the second edition of their very successful book Implementing CDISC Using SAS: An End-to-End Guide. This book is a very thorough summary of the current state of CDISC, as well as all of the tools that SAS has available for these data standards, including JMP Clinical!
Pick up a copy of Implementing CDISC Using SAS for someone on your “nice” list. Or better yet, for the truly well-behaved, why not a copy of JMP Clinical?