Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates.
Beth HarperZachary P SmithJane SnowdonRobert DiCiccoRezzan Hekmatnull Van WillisDilhan WeeraratneKen GetzPublished in: Therapeutic innovation & regulatory science (2021)
Mid-study database updates are disruptive and present a major opportunity to accelerate cycle times and improve efficiency, particularly as protocol designs become more flexible and the diversity of data, most notably unstructured data, increases.