Case Study: Roche achieves more accurate regulatory filings with JMP Clinical

A forward-thinking statistical monitoring program helps ensure smooth and accurate regulatory filings

Roche needed to strengthen clinical trial data integrity and ensure timely, successful regulatory submissions amid strict FDA and EMA requirements. To do this, Roche used JMP Clinical to proactively monitor studies for fraud, falsification, outliers, and other data quality issues before they reached submission.

With JMP Clinical, Roche implemented advanced statistical algorithms to flag questionable patterns and drill into issues early, enabling corrective action with study teams. The result was more consistent global monitoring, greater confidence in filings, and the avoidance of regulatory delays that could cost an estimated $6 million to $15 million per drug per day, while also helping Roche secure first-to-market advantages, patents, and exclusivity.

Roche

Chris Wells

Team Lead, Centralized Statistics Monitoring Group