Patrick R. Ayd, BSN, MBA
Advisor: Clinical Sites
What is the difference between a Capable site and a Marketable site? A “Capable” site relies on some skill and some luck. It all starts with your ability to pass a very intense Pre-study Site Selection Visit (PSSV). I tell my clients performing a PSSV without an awarded trial indicates something of significance wrong at their site. The Sponsor will rarely be honest with you and let you know exactly what it is. But trust me when I tell you that this is the case. In an effort to save time and money, many Sponsor’s no longer even conduct PSSV’s (part luck).
So what is a “Marketable” site? This is a site that relies on a solid foundation of procedures and skill (not luck) and welcomes Sponsors to take a very close look at their facility because they have nothing to hide. The SOPs are in great shape, the correct staff has been trained on those SOPs and the training has been documented. Their Investigational Product (IP)/Drug accountability process is one that can’t be beat or mistakes cannot occur. Their sample handling is also flawless with the right equipment to process PK samples, store the samples, and ship the samples as required, and so much more.
Capable vs Marketable Sites
I believe that the biggest difference between a “Capable” site and a “Marketable” site is that the “Marketable” site has an ongoing independent Quality Assurance program in place where someone unrelated to the organization comes to the site on a regular basis and audits the site to ensure they are following their own SOPs, GCP-ICH guidelines, the CFRs (code of federal regulations) and of course the protocol as written. The “Capable” site that believes they have no issues because a trial monitor has not put it out there acts as if having an FDA audit is of no concern where really they dread the thought of an FDA audit or even a full Sponsor audit. Whereas the “Marketable” site is used to having audits so they tend to have a “bring it on” attitude for both FDA and Sponsor audits.
Setting up and maintaining an independent Quality Assurance program is very affordable and in the long run your bottom line will see positive growth.
Contact BioAlliance Strategies for more information: http://goo.gl/PV31NZ