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.
Cancer therapies dominate 40% of the global clinical pipeline, and the field of oncology is leading the precision medicine revolution.
According to a 2016 industry survey, 80% of respondents agreed that Phase I studies are becoming more complex.
We know clinical trial complexity is increasing, so let’s investigate how it's happening across most dimensions of trial planning and management.