Skip Ribbon Commands
Skip to main content

CDISC

CDISC. 5 steps to information advantage 

​​​​​​​Since becoming FDA requirements, CDISC standards are set to become the single industry standard for regulatory submission and data exchange.
 
NNIT has a 5-step process that moves you stepwise from pre-analysis to implementation and organizational change management. The 5-step process is your assurance of an effective transition to CDISC data standards with minimal risk to on-going operations. 
 
Our 5-step process
  1. Conduct a system analysis of your entire system landscape
  2. Do a process analysis to identify your company’s unique way of working based upon SOPs and real life process
  3. Conduct a data flow analysis to uncover problem areas, risks and opportunities in your data flow
  4. Develop implementation scenarios for your consideration
  5. Select the implementation method
Once the right scenario and method has been determined, our change management team can help y​ou to successfully adapt to the new standards. 

NNIT can also help you to choose the appropriate governance model, taking into account your organization’s structure, maturity and business processes so you can maintain the standards.

 

 

 

Rasmus Koch Nelund+45 3079 6411rmne@nnit.com​​Vice Presidenthttps://www.linkedin.com/in/rasmusnelundRasmus Koch Nelund

 

 

CDISC implementation is key to optimised clinical trialshttps://www.nnit.com/OfferingsAndArticles/Pages/NNIT_Article_CDISC_implementation.aspxCDISC implementation is key to optimised clinical trials
Clinical Data Management solution for Choice Pharmahttps://www.nnit.com/CustomerCases/Pages/clinical-data-management-solution.aspxClinical Data Management solution for Choice Pharma