My assumptions are based on my experience working in a
My assumptions are based on my experience working in a major Pharma company .managed a team of professionals running the systems for the labs which was the clinical data along with other critical systems for the labs groups. Lots of interactions with the lab teams and with the fda as well as seeing how the process works to collect and cleanse data, how cumbersome it can be to “get everything right”, along with the double and triple checking that goes in with the reports. Everything needs to be nailed down tight when you lock the data down..timing can be all over the place based on several variables. So when I did my estimates I did them on average from my experiences but actually sped up the process by 2-3 weeks of when the report would be out because of the pandemic .
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