Everything Clinical Trials
Designing studies, capturing and monitoring trial data, managing investigator sites and everything in between.
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.
According to a 2016 industry survey, 80% of respondents agreed that Phase I studies are becoming more complex.
And it starts with study design.
We know clinical trial complexity is increasing, so let’s investigate how it's happening across most dimensions of trial planning and management.
Ingesting, integrating, standardizing, cleaning, coding, and analyzing disparate data sources creates complexity.