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Case Study

Achieving an Aggressive NDA Timeline

Imagine you are completing your regulatory submission project with only nine months left until submission day and you still have to migrate legacy data into SDTM ...

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Published Article

Adaptive Design- Recent Advancement in Clinical Trials

By John Balser, PhD and Mark ...

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Published Article

Biomarker Driven Adaptive Design for Precision Medicine

By Mark Chang, PhD

With an increasing desire for the use of precision medicine, an ...

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Infographic

Database Design Considerations to Improve Clinical Trial Efficiency

Nothing is more important in clinical development than collecting clean clinical trial data - especially if you plan to use that data for your marketing ...

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Webinar Presentation

Different Approaches for Preparing a Marketing Application

Preparing your marketing application for one or more regulatory agencies is a very exciting time and milestone in the drug development process. 

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White Paper

Essential Considerations for Adaptive Design in Clinical Trials

In 2016, the Food and Drug Administration (FDA) released final guidance on adaptive design in medical device trials with the intent to provide clarity on adaptive ...

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Infographic

FDA Expedited Pathways

View the infographic to learn how to leverage FDA’s expedited pathways to accelerate product development. We outline the requirements, benefits, and procedures for ...

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Infographic

FDA Meeting Types

View our FDA Meeting Types Infographic to learn about Type A, Type B and Type C meetings – with specific insights into meeting timing, purposes and examples of each ...

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Webinar Video Replay

How To Ensure A Successful FDA Meeting

Watch our webinar to learn about the value and types of FDA meetings, how to write your questions for FDA, what to include in your briefing package and how to prepare ...