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Project Management

1 min read

On-Demand Webinar: Natural History Study for Ultra-Rare Diseases

Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an Extraordinary Natural History Study – Navigating the Patient Experience When Pivoting to a Virtual Model Mid-Study”? 

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2 min read

Regulatory TOPRA Webinar: Latest Regulatory Experiences

Each year, Veristat regulatory experts present timely, relevant topics to members of The Organization for Professionals in Regulatory Affairs (TOPRA), a UK-based organization committed to driving regulatory excellence across the healthcare regulatory...

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3 min read

Joining HIPRA to Take Aim at the Continuing Challenges of COVID-19

Clinical trial activity remains strong in the area of new vaccine development, as COVID-19 continues to impart tremendous health and societal impact on our world. 

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2 min read

A Paradigm Shift in Monitoring Clinical Trials

What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.

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3 min read

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

 

Veristat has experience in preparing more than 120 marketing applications.  Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:

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3 min read

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

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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2 min read

Top 10 Operational Tips for Navigating Complex NDA/MAA 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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