Submissions Are Significantly More Difficult Than Clinical Trials

There’s no two ways about it: Submitting your work is significantly more difficult than earlier stages of clinical trials. That’s because you have to integrate all of your previous analysis into a single, cohesive whole. Those studies might stretch back as far as a decade. What makes the process even more challenging is that these studies must conform with current FDA standards.

You will get some guidance at the end of Phase Two, but that guidance might not be worth much by the time Phase Three comes along. It will have driven your research and analysis throughout Phase Three, but it won’t tell you much about how you should present your data and analysis to the FDA when it comes time for Phase Three approval.

It’s not unheard of for everything to fall apart during submission. The burden of integrating a decade or more of data, analysis and research can prove too much for some companies. This is why you need a CRO that specializes in biostatistical data analysis. We discuss these and others in more detail in our recent white paper.

Partnering with a CRO specializing in biostatistical data analysis increases your chances of approval by dealing with late-stage analysis problems in accordance with the most current FDA practices.  Our next blog post will discuss how late stage analysis can save the day.

Next Steps:

Read our analysis on other topics related to Getting FDA Approval.

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