I feel confident that the company has all the clinical trial advice they could possibly need.
Psi-CRO is a large Swiss-based multinational that runs clinical trials as their bread-and-butter business. They could do this blindfolded.
http://www.psi-cro.com/
http://www.sec.gov/Archives/edgar/data/1552899/000119312512365687/d365958dex108.htm
They've also been getting advice from Practical Clinical in Canada. The principals there cut their teeth with Abraxis.
I think suggestion of deficiencies in trial design associated with number of sites, patients per site, quality of sites, etc. is probably misplaced. Psi-CRO has people on the ground in a heck of a lot of countries. It's worth reading the contract above to see the level of detail specified. Also.... something we have had feedback on is patient recruitment. Completion was almost exactly as indicated at the start of the trial. I thought that spoke well of trial management.
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