Innovation Pharmaceuticals Inc (IPIX)

[LilyGDog]

Sunspotter...

YOU KNOW: The FDA sets forth in minute detail how a Clinical Trials will be run, and a Full Service CRO will have to comply and confirm to the FDA and company that those details have been fulfilled at all sites... IF CRO fails to carry out its mission...it does not get paid. The FDA is final judge. That is why a small biotech, (and most BP) hires a full service CRO. Internal non-officer admin company employees have very little do with the actual physical trial...

CRO supervises ALL aspects of trials...from strategy, to regulatory compliance to the following details:

1. selecting, in consultation with company, trial sites,
2. to the pre-inspection (they already know, because they know reliable sites from being there before,
3. to shipping of medical equipment specified by FDA/IND, type of equipment and materials used...
including, but not limited to:
A. the Basic IV Equipment, B. Administration Sets, C. Needles, D.Basic Types of IV Solutions,E. Devices for Regulation of IV Administration, F. Devices for Holding Infusion Fluids,
G. Supplies for Applying Local Anesthesia (if necessary or relevant before Venipuncture H. Supplies for Protection of Infusion Site, I. etc., etc., etc.

Additionally,a TOP FULL SERVICE INTERNATIONAL CRO will use sites (unless a site is used which has been insisted upon by the the company) where they have had a continued employee presence and experience...they know the reliable sites, they have their pulse on the patient flow and competing studies (if any) within the hospitals, and guide the companies who engage them and after consultation with Clinical Trial staff at hospital site.

CRO knows which sites are likely to fill the patient needs of the trial asap.

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

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

IMO... IPIX will have hired one of the world top "full-service" CRO's to fully comply with company's obligation under FDA/IND Clinical Trials...