CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’. The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are increasingly expected for use in data submissions by regulatory authorities. Importantly, data standardization also brings significant benefits to the industry- in the CDISC 2014 Business Case (1), it is noted that:
“For those developing regulatory eSubmissions, using updated baseline numbers for the time and cost of getting a drug to market, it can be found that ~ $180M can be saved per submission (18% of the total cost). An average of two years can be saved off of an average 12-year clinical development program lifecycle – just by standardizing data”.
It’s therefore critical that the biopharma and CRO industries develop the next generation of data managers, statisticians and programmers with strong knowledge of the CDISC standards.
Angelo Tinazzi has more than 20 years’ experience in data-management and statistical programming and is Director of Clinical Data Standards and Data Submission at Cytel. He has been a member of the European CDISC Committee since 2015 and is a member of the CDISC ADaM team. Taking the next step in his journey as a data standards expert, Angelo is now a "candidate trainer" with CDISC –working towards becoming an “Authorized CDISC Instructor”. In this blog we find out more from Angelo about his experiences and the role of the CDISC trainer.