“Getting your data out, super important before you go into a tool implementation, that should be clear in the contract, that you can get your data out.”
MS
Mandy Savoca
In-House Outliers ·
“Make sure you have the right to the research, the right to use the data… data traceability all the way through the process.”
Bethany Hills · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
Play from 39:36
39:36
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What was described
Secure data rights and traceability through data-use agreements, partner contracts, or purchases before submitting RWE to FDA
Said nearby on the same subject
“The data must be accurate, complete, and traceable back to the source to allow us to do source data verification.”
MD
Meryl Dersarkissian
FDA Watch ·
“Right training for their team, the right AI tools accessible, the right guard rails, good data security ... one of the first things people look at in due diligence”
OD
Otto Dargan
The Deal Room ·
“…the plan sponsor owns the data. The plan sponsor must have access to the data… they’ve signed the rights away when they signed the contract.”
FP
Frank Panaccio
Relentless Health Value ·
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