The aggressive demands in current global drug market are pushing the biopharmaceutical companies to embrace innovative ways of lessening drug development timelines and in augmenting productivity. The successful use of data-capture systems may guarantee that high-precision data are obtainable for early assessment and speedy decision-making.
The integrity and value of data being gathered and passed-on from human subjects to a clinical data management system (CDMS) must be supervised, sustained and evaluated as it can be a functional source for not only new drug application (NDA) submission and to generate reports on final outcomes but also for trial planning, decision-making, process upgrading and to evolve at fool proof clinical trial process implementation.
The gradually increasing use of electronic data-capturing (EDC) technology and effective data cleaning methods and discrete data management plans (DMP) has transformed the activities of clinical research operations for sponsors, contract research organizations and sites. The clinical data management operations will start from data collection thru data cleaning, data validations, collecting the adverse events and coding with relevant medical dictionaries, final checks for the quality before the database is finally locked.
CDM process demands broad range of skills such as scientific, technical, IT, systems engineering, project management and interpersonal skills to handle, drive and offer esteemed services in managing clinical data in this e-clinical era.