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Beating Rare Cancers Requires Your Help - JOIN THE BATTLE TODAY!

January 11, 2019

As a scientifically oriented and impactful full-service clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology, and medical device firms to advance their therapies throughout the entire clinical development and regulatory submission process,  Veristat works each day with a focus on improving the lives of patients with rare cancers

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More Seats at the Table | The Growth of Female Leadership in Healthcare

December 5, 2018

As a Talent Acquisition Consultant for Veristat, I receive many cover letters and resumes from candidates each day. I am often blown away by the experience, knowledge, and expertise of these individuals and always hope to match their skill sets to one of our current openings. 

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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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