Persly Research for regulatory affairs

You can build regulatory evidencewithout enrolling anyone new

Control arms you cannot enroll, and off-label use already in the data.

Summarize tumor marker levels over time after treatment in patients on Keytruda

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Use it as RWE.

Rather than enrolling new patients, build your clinical evidence from the data of patients already in the record.

Expand your label
Find where your drug has already been prescribed outside the label and see whether it actually worked. You can assemble that evidence for an FDA submission.
Replace the control arm with data
In rare and severe disease a placebo arm is often not ethical to run. Build that comparator from Persly's data instead. An external control arm assembled here supports the comparative effectiveness case and can go into an FDA submission as fit-for-purpose real-world evidence.

Is IRB review not required?: The exploratory stage runs without review. Results are de-identified and counts for very small groups are not shown, so it does not constitute research using identifiable information. Once you settle on a hypothesis and move to the study itself, IRB approval is required.
Is patient personal information visible?: No. Every identifier is removed before analysis, counts for very small groups are not shown, and only the minimum clinically meaningful information is used.
Can results be used for publications or regulatory submissions as is?: Not as is. Once you have IRB approval, you can review the de-identified source records behind a finding and use them either as a citation in your paper or as supporting material in a regulatory filing. We help you prepare for that review.