Innovation Pharmaceuticals Inc (IPIX)

[sunspotter]

1) "CRO supervises ALL aspects of trials...from strategy, to regulatory compliance"

No. The responsibility for every aspect of the study rests with the Sponsor of the study, in this case IPIX:

"Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols"

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.3

The CRO is contracted (the clue is in the term Contract Research Organisation) to perform some of these aspects for the Sponsor, but the Sponsor remains legally responsible for every aspect of the study - the CRO can be audited by FDA in its conduct of the study, but any findings are applied to the Sponsor as it is the Sponsor's responsibility to ensure the CRO complies with all necessary rules and regulations.

2) "They also interact with the FDA re: compliance with the trial requirements...and validated lab results done in U.S."

Actually they can't. All these matters remain the sponsor's sole responsibility. They can and do prepare documentation for the Sponsor, but that's about as far as it goes.

3) "If CRO does not perform according to their function...they do not get paid. Great incentive to do it right."

Worded so vaguely as to be meaningless, but essentially if you're Pfizer, AZ or GSK you might get some kind of rebate if things don't go to plan.

OTOH if you're IPIX you pay most of the costs upfront, with a few downstream milestones and the contract has so many loopholes for the CRO to worm through they'd have to completely screw it up to give any kind of refund.

I've signed literally dozens of such contracts on behalf of my pharmaceutical employers, so I know whereof I speak.

Other than those gross factual errors JTFM's post was spot on.

BTW if you want me to address a post of yours, you should use the Reply button so I see it in my mailbox.