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Response Data

The data that’s the most valuable is the response data coupled with the safety data. Knowing that a subject is in CR based on objective criteria could mean the difference in outcome for the study...and the subject. The Protocol First EDC captures RECIST identification, observations, and response assessments in solid tumors or lab values for blood cancers. All of this data is available in industry standard CDISC SDTM data format that’s available in real time for analysis using standard tools for response. Having this data clean and available for analysis can make the difference of presenting an abstract at this year’s conference or next year’s.