4 ms·
What kind of liabilities? That looks like a case against an individual. Are you talking human counter-intelligence as well as IT security?
by vsareto 6y ago
What kind of liabilities? That looks like a case against an individual.
Are you talking human counter-intelligence as well as IT security?
- akiselev 6y agoImagine a state actor hitting the contract research organization in charge of the last phase of a clinical trial for a blood pressure medication and changing data. Due to the nature of double blind trials, catching these modifications can become really hard to catch and could lead to a lot of human suffering.
- La1n 6y agoIf they target a CRO the sponsor still has the original data from the trial sites. I can say that at least for the company (one of the 10 largest pharmaceutical companies) I work for this would almost be impossible to not be caught.
- Icathian 6y agoEven the crappy little cowboy CRO I worked for had a fleet of CRA's go out and manually verify documents against the EDC. It's required by law. I think the FDA audit also repeats that process with a random sampling for some studies, though I couldn't swear to that. I get the point the parent comment was trying to make, but yeah, bad example.