Abstract
A new model for conducting clinical research programs in the future is beginning to evolve which will emphasize collaboration, interdependency, and close interactive sharing of information among the various stakeholders in the research process: patient, investigator, sponsor, project manager, medical monitor, data management organization, laboratories, biostatisticians, and regulatory authorities. This model will conserve the use of information by minimizing redundancies, transcriptions, and data conversions in a continuous data flow, simplifying the data clarification process, and using the “best fit” technology tool for capturing and accessing clinical information. This view of clinical research will be based on a generic data repository based upon evolving International Conference on Harmonization/Food and Drug Administration (ICH/FDA) data standards which will also support trials management and safety monitoring with respect to the data repository. The current state of alternative data capture technologies such as interactive voice response systems (IVRS), remote data entry (RDE), image recognition, Internet technologies, hand-held computers, voice recognition, and wearable monitoring devices will be reviewed.
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