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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...
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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...
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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...
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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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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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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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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...
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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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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,...