The Innovation Committee is publishing topic briefs intended to serve as orientation guides on specific areas which are contributing directly or indirectly to the evolution of CDM into CDS. Take a look at the latest topic brief published: The 5Vs of Clinical Data.
The evolution of clinical research practices and supporting regulations, as well as massive advances in technology have fundamentally changed what clinical data is. As we define the future beyond traditional EDC, we need to rethink our approaches and understand how the “5 Vs” of data are re-shaping CDM. First and foremost, it is evident that not all data is created equal. Therefore, our data strategies need to be commensurate with the risks, complexity, and value of the data collected. Additionally, data security and personal data protection are key elements that must be strategically anticipated and addressed prior to trial start. If the true value of this data is to be realized, it must be collected and captured in a consistent and timely manner that considers all 5 V dimensions.