Data sources have grown exponentially over recent years, adding significant complexity to the lifecycle of studies and increasing risks to timelines and...
Data sources have grown exponentially over recent years, adding significant complexity to the lifecycle of studies and increasing risks to timelines and budgets.
Clinical Data managers are responsible for defining how clinical study data will be collected, and managed, in relation to the intake and quality of the data...
Clinical Data managers are responsible for defining how clinical study data will be collected, and managed, in relation to the intake and quality of the data throughout the trial. While this sounds simple enough, it has become an increasingly challenging task due to changes in technologies, processes, regulations, and the growing complexity and diversity of the data.
Clinical Data managers are responsible for defining how clinical study data will be collected, and managed, in relation to the intake and quality of the data throughout the trial. While this sounds...
As of January 2018, the Clinical Data Interchange Standards Consortium (CDISC) will provide its Platinum members with access to its Shared Health and Research...
As of January 2018, the Clinical Data Interchange Standards Consortium (CDISC) will provide its Platinum members with access to its Shared Health and Research Electronic library (SHARE), a set of technologies the CDISC uses to develop and manage industry clinical data standards.
As of January 2018, the Clinical Data Interchange Standards Consortium (CDISC) will provide its Platinum members with access to its Shared Health and Research Electronic library (SHARE), a set...
Recently, the FDA published an article describing a notification it had issued to a contract research organization (CRO). The notification required certain...
Recently, the FDA published an article describing a notification it had issued to a contract research organization (CRO). The notification required certain bioequivalence studies to be repeated based on improper data collection and analysis processes. Bioequivalence studies, often conducted to bring generic drugs to market, establish that the generic drug has the same ‘effect’ as the original drug. Obviously, these are critical trials, as they also establish the safety...
Recently, the FDA published an article describing a notification it had issued to a contract research organization (CRO). The notification required certain bioequivalence studies to be repeated based...
