Replies to post #249474 on Innovation Pharmaceuticals Inc (IPIX)

[frrol]

I suspect the slow recruitment / added sites were the origin of the overruns dispute.

[wsbc]

Super interesting.

Also a great comment at the bottom as well, concerning oversight and qualification of staff/management:

A good article and some candid points well made. It would be good to see a follow up article from a CROs perspective. I work for a company that independently verifies the competence of staff (in both pharma and CRO). We're currently working on a quality initiative that allows a sponsor a transparent overview of quality of staff benchmarked against industry : one of the big 7 CROs are doing this to demonstrate quality to their sponsors. I would say when we assess the competence of Project Managers, especially with respect to timelines, budget and resources, you see a very big difference in understanding between pharma and CRO.

-Fiona Wallace

[scottsmith]

Is there anything you think Leo did do poorly? In real time of course. Ha!

[PlentyParanoid]

Thanks, Karin. Enlightening.

[blanka]

Miseta: Are cost overruns and change orders a challenge for you?

Smith: Yes and I think that is primarily due to two things. First, there are times when we are forced to change or amend the protocol or add patients. Obviously that will result in a legitimate change order. It is not a problem and I am happy to pay for it. But I have been involved in projects with CROs where we seem to be paying for project management, and those charges can be really steep.

I have seen CROs submit change orders for things such as sending a memo to a site. Something came up, they had to let the sites know, and they submitted a change order as a result. To me, that is simply project management. It’s ridiculous to think a sponsor should pay you extra for having to send out a memo. Situations like that make me feel like I’m being nickel and dimed.

Here is another situation that came up recently: We went to a CRO and asked them to give us a fair per-patient price. We have very aggressive timelines and we wanted to produce a budget that was reasonable and would not require a lot of negotiation. We used the amount provided but still ended up having to negotiate every budget. Overall we were about 30% lower than what the sites ended up agreeing to. That is frustrating because the CRO knows the patients, they know the sites, and they know their costs. We admitted up front we didn’t know and wanted to prepare a fair budget. They should be able to produce a more accurate estimation of costs.

Very INTERESTING Indeed...

[thefamilyman]

Good info. Thanks Karin.

[Rdunn88]

Leo added patients/sites to the last P trial? IPIX's CFO/CEO made some lousy budget projections.