The what, the why and the how of a holistic, quality-based approach to monitoring
In this two-part blog, we’ll first explore the technology roadmap to RBM we outlined and discussed, and next week we’ll bring you some key themes addressing practical considerations in adopting an RBM approach in your next clinical study.
When it comes to submitting new drug applications to FDA, it’s safe to assume that the prospect of receiving a complete response letter keeps pharma executives up at night. The risks associated with regulatory submission can have a substantial impact on a business, and approval delays due to data issues can cost a company millions.
As a former FDA reviewer, I’ve seen just about everything when it comes to data quality issues that can derail drug approvals. Luckily, today these kinds of risks can be mitigated using sophisticated data analytics.