The topic of Brexit tends to generate more questions than answers.
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.
Ingesting, integrating, standardizing, cleaning, coding, and analyzing disparate data sources creates complexity.
When optimizing your study practice, it is vital to evaluate every trial phase in context.
While new guidance has created a much needed sense of urgency to define a risk-based monitoring approach to clinical trials, there is one critical area of monitoring that cannot be ignored.