Decentralized trials and/or new trial designs are causing a rapid increase in the variety of data sources used in trials. To meet a growing list of guidelines for Good Clinical Practice (GCP), including International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) and the impending ICH E6(R3) this data must be carefully collected and analyzed.
The biopharma industry will continue to modify clinical trials, which will produce changes in the resulting data. With new kinds of data—likely more complex collections of data, and surely more data—biopharma companies will face increasing needs for software that overcomes challenges from data analysis to overall company performance and product quality.
By centralizing analysis and communications, a biopharma company creates a system based on connectivity and automation, aggregated and usable data, flexible analysis, and methods of collaborative data review.