Case Study: Leading Pharmaceutical Company achieves FDA submission readiness and 2019 approval after cleaning six years of clinical-trial data with Clario

Collaborative data management activities to prepare six years of data for submission

Leading Pharmaceutical Company faced a major submission challenge after a six-year, ~8,000-patient, 450-site study produced large volumes of uncleansed clinical data. Clario was subcontracted to provide EDC, CDM and IRT services and had to overcome communication gaps, high turnover and the absence of an early submission plan to get the study ready for database lock and regulatory review.

Clario implemented a coordinated remediation plan using phased “waves” of cleaning (≈1,000 patients per wave), a shared master spreadsheet of tasks, integrated EDC/CDM/IRT workstreams, endpoint and SAE reconciliation teams, and a follow-the-sun support model. As a result, all historical data were cleaned and available for analysis by the end of 2018, the Clario IRT team processed 1,200+ of ~7,800 data change requests in the final year, and the drug was approved by the FDA in 2019 following submission and audit.