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Protocols for submitting real-world evidence packages differ from traditional protocols in a variety of ways. For regulatory submissions, real-world data analyses must conform to the strict requirements of a clinical trial, including independent double programming. Programming code and algorithms submitted to the FDA must be well-documented, well-annotated, and complete enough to allow the FDA to replicate all study analyses and findings. Special thought must be given to those analyses unique to real-world data that traditional trial statisticians may not be familiar with, such as inverse probability of treatment weighting. Learn more in our full video series: https://lnkd.in/ghGG8G_Q #lifesciences #biotech #slipstream

Andre Chapman

CEO & Startup Advisor - AI, Data, Analytics, Agile, Product - Staffing & Solutions

2w

Tom, Brandon looks like you guys are doing some awesome work at Slipstream, excited to see how your content and service offerings are expanding and positvely impacting clients in the Life Sciences space, well done!

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