I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redations are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me those letters and numbers had a meaning. I had an aha (and… [Read More…]
When is a CRO not a CRO?
(And why does that make enforcement hard?) What do the following companies have in common? Electronic data capture (EDC) software providers Central image / electrocardiogram (ECG) / spirometry readers Central clinical labs Electronic patient reported outcome (ePRO) software providers They’re not Clinical Research Organizations. That’s right. They’re not CROs. When you finish this, you’ll be… [Read More…]
