Everything Clinical Trials
Designing studies, capturing and monitoring trial data, managing investigator sites and everything in between.
Digital transformation: this is one of the hottest topics in our industry today, creating both opportunities and challenges for our customers. For pharmaceutical, biotech, and medical device companies, the promise of making data-driven, insights-led decisions in real-time means getting the right treatments to the right patients at the right time. To truly realize this potential, they need to rely on combined insights from both clinical and commercial data.
So far Edge Trial Assurance has been used in 30 trials. It has detected 50-75 data anomalies in every single trial.
Genomic data is being integrated into clinical trials—sometimes not so successfully, and sometimes very, very successfully.
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.