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Informative Article | Life Sciences | India | Volume 11 Issue 10, October 2022

Clinical Data Management: The Fifth Deflection Point

Robert Robinson

Abstract: At this moment in time, Clinical Research and Clinical Trials are undergoing a massive overhaul and transformation, and the areas that are most exciting are driven by transformation in Process, Platform, Technology and Digital Consulting. Every Pharmaceutical company, no matter how small, now must manage a truly enormous amount of clinical data with all its subjects, sites, studies, standards, etc. The shift of balance is more towards patient value and core research and not so much on clinical trial operations. Over the last two decades, there have been five major deflection points in Clinical Research, let us take a sneak peek at the Deflection to understand its evolution even as we turn back and look forward to the fifth wave of Clinical Data Management where this area has evolved from a traditional, conformed operations program into a transformed, revolutionary data science. In this article we look at five deflection points over a decade from emergence of EDC, beyond EDC, Digital Transformation, Covid Times and Now. The best is yet to come, even as we look forward to more adoption of decentralized trials, scalable integrated, unified data ecosystem, more real-world data, site less trials, virtual trials, incorporation of artificial intelligence; data managers transitioning into a data science role ? the 5th deflection point is exciting driven by digital transformation, driven by strategy, driven by passion. The fifth deflection point is Now, and it is here to stay.

Keywords: Deflection Point, Clinical Data Management, Emergence of Electronic Data Capture, Looking Beyond Electronic Data Capture, Digital Transformation, Covid Times, Unification of Platforms, Advanced Standards

Edition: Volume 11 Issue 10, October 2022,

Pages: 515 - 516