Case Study Turning RWD into RWE: External Control Arm for Label Expansion Posted on March 23, 2021 Situation A large global pharmaceutical company aimed to use real world data as an external control arm in their ongoing studies. They required access to a number of data sources as well as technological capabilities to generate data for their rapidly approaching regulatory filing deadline. Specifically, they sought to supplement studies with comparator cohorts in hematological malignancy. The required cohorts were highly segmented based on the inclusion criteria and data parameters defined Challenge Team was unable to access the required data for several months due to the common challenges of accessing global real world data: identifying relevant cohorts, understanding and manag

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