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White Paper: Smoothing The Road To An NDA
By John Jordan
Even when enrollment for a clinical study is completed on schedule (it does happen sometimes), getting from Phase 1 trials to the submission of a new drug application (NDA) may involve roadblocks that stand between the clinical study team and analysis of the final datasets. Running up against such barriers is particularly common in studies that need to collect patient-reported outcomes — more specifically, studies that choose to collect such data in paper-based systems.
Used with permission from Life Science Leader magazine.
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