Imagine you are completing your regulatory submission project with only nine months left until submission day and you still have to migrate legacy data into SDTM format for 18 studies as well as 2 ongoing pivotal studies.
Adaptive design (AD) trials are increasingly popular as they offer the ability to reduce the overall time and cost of running clinical trials. And, they improve patient safety by minimizing exposure to unsafe or non-efficacious treatments.
After years of inefficiencies in the clinical trial process, adaptive design trials provide an innovative approach to running a clinical trial and bringing a drug to market.
With an increasing desire for the use of precision medicine, an understanding of biomarker-driven designs is vital when preparing for a clinical trial.
With Cardiovascular Diseases being the leading cause of death worldwide, Veristat is committed to supporting cardiovascular clinical trials to make a difference in the lives of those suffering from these diseases.
Competing risk analysis methods present a new way to understand how an event could minimize the chance that a subject will reach the desired endpoint necessary for a clinical trial.
Preparing your marketing application for one or more regulatory agencies is a very exciting time and milestone in the drug development process.
In 2016, the Food and Drug Administration (FDA) released final guidance on adaptive design in medical device trials with the intent to provide clarity on adaptive design planning and implementation, and to encourage its use.
Veristat can provide its regulatory submission expertise both in the US and abroad. We can assist you in achieving regulatory approval with our team of experienced medical writers and strategic consultants.