September 27, 2016 Princeton, New Jersey: Navitas Life Sciences releases paper on CDISC, the standards and why the upcoming December 18th FDA deadline matters
The FDA (and eventually, regulatory agencies from around the world) will require clinical data sent to them to be in CDISC standards. Georgina Wood, Navitas’ Clinical Data practice leader writes about CDISC, the various standards and what it all means for the industry.
click here to download the whitepaper.
About Navitas:
The Navitas Life Sciences team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting. We have built the Navitas Life Sciences team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advise, solutions, and services in Clinical, Regulatory, Safety, and Content Management. We are proud that our legacy businesses have served the sector for some 20 years and have allowed us to work with 100 of the top Life Science companies. Our team have now grown to over 400 staff.
We pride ourselves in our role as Expert Navigators. Interpreting market and regulatory change; driving collaboration across companies; seeking the simple solution to the complex problem; investing to enable the changes. Motivated by the success of our clients, we thrive on working together with clients, partners, and each other, across geographies, time zones, and cultures. For more information, visit www.navitas.net.