Replies to post #149412 on Biotech Values

[NP1986]

I would assume that it would have to be stipulated in the contract and who the CRO in question is. In the Indian clinical trials registry, PRA international is listed as the trial coordinator for the Indian sites. Of course, this doesn't mean that they are the culpable party as we don't know where the discrepancies came from or which other contractors, if any, were involved.

[iwfal]

PPHM -

What I do understand about this CRO fiasco is that it happens, not often, but when it does the quilty CRO is responsible for doing a new trial.

True or dependent on the specific contract?

And what happens if there is a different CRO in India than in EE - and yet both have similar problems while showing stellar efficacy?

As for the particular legal question you asked - as someone noted it would depend upon the specifics of the contract.

[masterlongevity]

dependent on the contract, but most likely the CRO will have to pay some penalty but not be financially responsible for a full trial. You wouldn't want that same CRO doing the next trial anyway.

This is hard to blame on a CRO as the sponsor should have oversight. Every trial I have worked on as a separate unblinded person (in the company or consultant) who doublechecks the vendors's(CRO) treatment assignments.

Randomization and treatment assignment mishaps are the most important aspect to control and have good oversight on because they can completely ruin a trial. You can be hands off in other areas if you are low on resources, but not in this area.