One of the major hurdles when launching a new drug is the approval of chemistry, manufacturing and controls (CMC) data, which is necessary in order to begin clinical trials and obtain final drug marketing authorization.
CMC modules are uniquely challenging because they:
As a result, many new drug approvals take much longer than planned because of deficiencies in their CMC data, leading to extended timelines, unplanned costs and testing, and loss of forecasted revenue.
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* $2.9B was the average R&D budget for the 17 large and mid-sized companies in CMR
1. 2018 CMR Factbook from Clarivate Analytics: Drawn from the 2018 R&D Investment Metrics Programme