Bioequivalence and Bioavailability Forum

Hi all,

❝ Samples substituted or diluted. Stupid enough to keep a spreadsheet documenting the manipulation on the server. ......

In a weird sense of data integrity concept, they did it quite well. How many CROs you guys know that documented all their manipulations nicely and orderly and put it out on their server (so somebody can find it later and trace the source of manipulation)?

Now seriously: One subsidiary of our group in USA had done many studies in that CRO and FDA requested them, a couple of days ago, to repeat all studies in their ANDAs in another CRO. The worse thing is, they still got many studies from the same CRO that have not been submitted yet. So they are seriously screwed.

Fortunately we don't use the same CRO and I only know Semler from the bad news they told us last week. So my question is, what can sponsors do to avoid this kind of unfortunate situation? All studies have been monitored but obviously monitors didn't find anything. It seem every time when there's major screw-up the one to find them are almost always regulatory agencies.