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Case Study
Achieving an Aggressive NDA TimelineImagine 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 TrialsBy John Balser, PhD and Mark ...
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Infographic
Database Design Considerations to Improve Clinical Trial EfficiencyNothing 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 TrialsIn 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 PathwaysView 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 TypesView 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 MeetingWatch 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 ...
