White Paper

Improved Data Quality & Integrity For Faster Regulatory Approvals

Source: Medidata Solutions
Improved Data Quality & Integrity For Faster Regulatory Approvals

A study examining all new molecular entity (NME) applications first submitted to the FDA between 2000 and 2012 found that several potentially preventable deficiencies account for significant delays in the approval of new drugs. The difference in approval time between NMEs receiving first cycle approval and those requiring multiple cycles is 17.9 months, so any delay can materially impact revenues. Moreover, estimates show that up to one in six NMEs fail first cycle approval due in part to data integrity issues. Data quality and integrity issues are leading contributors to deficiencies in clinical trials. Assessing data quality prior to regulatory submission and database lock can save months of manual investigation and surface unknown data integrity issues that would otherwise materially impact a submission.