Avid Bioservices Inc (CDMO)

[Protector]

Bio, no I think that will rather be because of possible problems occurring during clinical trials, or the preparation thereof, where changes are not properly managed and where a software/database error can have serious consequences.

e.g.: PPHM's Fargo dose switching is very probably a software or database problem, leaving in the middle the topic of intend or not.

I thought everybody (all companies) involved in software development and data(base) management would have a project management system such as Prince II, or for ICT the more lightweight ITIL implemented.

The fact that in the beginning of the year the FDA had to set rules for the handling of data and software in clinical trials probably means that in a majority of companies in the Pharma/Biotech business performing proper project/asset/change management isn't done at the extend needed.

Then again, when researching Gerald Finken (the CEO of our CRO CSM in Fargo, ND) he seemed to be quite involved, and even a leader, in setting procedures specifically to manage clinical trials. He even filed for a patent in that area.