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When Veristat Walks – Cancer Runs

October 3, 2018

In 1964, a child’s chance of surviving the most common form of Leukemia was 3%.  Today it has increased to 91%!  

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What Pharma Companies Need to Know Before Designing an Adaptive Clinical Trial

August 31, 2018

By John Balser, PhD, President, Mark Chang, PhD, Senior Vice President, and Robin Bliss, PhD, Director

The Food and Drug Administration (FDA) has started encouraging the use of adaptive designs for clinical studies. In essence, adaptive designs allow prospectively planned modifications to a clinical trial based on interim data, provided scientific validity (the ability to draw sound inferences) and data integrity (credibility and reproducibility) are preserved. 

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Is Your Complex NDA/MAA Submission Missing One of These Key Elements?

August 21, 2018

By Martha Plaza, MBA; Amanda Truesdale, MA, MBA; and Kimberly Newton, MA. 

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Key Strategies for Overcoming Data Analysis Difficulties During NDA/MAA Submissions

August 14, 2018

By Amanda Truesdale, MA, MBA, VP Biometrics

When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?

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Streamline the Medical Writing Process for Simultaneous Submissions

August 6, 2018

By Kimberly Newton, MA, Senior Director Medical Writing

When a team faces multiple submissions in a short timeframe or even simultaneous submissions, uncertainty over timeline organization and the best way to utilize medical writers can be paralyzing.

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Planning to Relax: Scheduling Time Off So Everyone Benefits

July 30, 2018

With the summer in full swing, vacations and long weekends by the pool are top of mind.

Although we all have the best intentions to use our paid time off each year, it is also not a secret that Americans are truly terrible at taking time off.  According to Project: Time Off, 52% of American employees reported having unused vacation days at the end of 2017.

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Top 10 Operational Tips for Navigating Complex NDA/MAA Submissions

July 27, 2018

by Martha Plaza, MBA, Project Director, Regulatory Submissions

No two New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs) are the same. However, they all have common aspects that create the opportunity for streamlined operational tips. 

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Flexibility is the Key to Data Acquisition for Rare Disease Trials

March 27, 2018

Understanding Why Creative Solutions Are Necessary

With last month’s celebration of Rare Disease Month and specifically, Rare Disease Day, awareness of the research challenges faced by patients and pharma companies are especially high during this season.

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Painting in the Dark | A Shift to Quarterly Conversations for Improving Employee Engagement

March 21, 2018

Have you ever tried to paint a room in the dark? Probably not, right? 

Why would anyone go through the trouble of getting the supplies and putting in the effort to attempt a job well done if they couldn’t see their progress along the way?  Just the same, why would anyone turn their career over to the annual performance review process? 

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Join Veristat To Support Rare Cancer Research

January 10, 2018

CYCLE FOR SURVIVAL 2018

Every dollar represents hope, strength, and a lasting impact!

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