When you think about clinical data these days, it’s easy to focus on data integrity and compliance over anything else. This is likely due to the increased attention these have received lately, and it makes sense when you think about the consequences of not being compliant with current oversight regulations. But what if we start to think beyond compliance alone, and start to put that data to work?
2018 was a big year with respect to big data and analytics. Not just for clinical trials, but the field overall as it relates to the collection of data, the analysis and deep-mining for patterns and the interpretation thereof to inform strategy. Banking and manufacturing are two industries that are particularly adept in the field but health sciences is not far behind.
The importance of compliance was always there, now it’s more important than ever with the proposed fines, how many responses will be submitted to the Draft Guidance and what will the final directive look like?