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Stats & Programming

1 min read

Planning the Way Forward for a New Tumor Evaluation Modality

RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...

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1 min read

Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?

In this case study example - yes.

Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...

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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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3 min read

Flexibility is the Key to Data Acquisition for Rare Disease Trials

Understanding Why Creative Data Collection Solutions Are Necessary

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