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Achieving an Aggressive NDA Timeline

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. 

Case Study

Adaptive Design Fact Sheet

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.

Fact Sheet

Adaptive Design- Recent Advancement in Clinical Trials

By John Balser, PhD and Mark Chang, PhD

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.

Published Article

Biomarker Driven Adaptive Design for Precision Medicine

By Mark Chang, PhD

With an increasing desire for the use of precision medicine, an understanding of biomarker-driven designs is vital when preparing for a clinical trial.

Published Article

Cardiovascular Experience Infographic

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.

Infographic

Competing Risk Analysis in a Large Cardiovascular Clinical Trial: An APEX Substudy

By Douglas Arbetter, MPH

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.

Published Article

Different Approaches for Preparing a Marketing Application

Preparing your marketing application for one or more regulatory agencies is a very exciting time and milestone in the drug development process. 

Webinar Presentation

Essential Considerations for Adaptive Design in Clinical Trials

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.

Insight Brief

European Rare Disease Infographic

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.

Infographic