CRO subsidiary of pharmaceutical company [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-07-09 21:21 (591 d 07:01 ago) – Posting: # 23122
Views: 1,820

Hi ElMaestro & Osama,

❝ b. We need to bear in mind that many originators still have clinical departments that act as the company's own CRO (the only real difference being it may be called a division rather than a CRO). Would we also enforce a COI concern over those clinical departments? Why? Why not?

❝ c. Defining what a "relation" is, and what is means to be "owned" etc is a legal mess. This is the playground of lawyers. I am sure that if we were to make an amendment in a guideline to the effect of "CROs cannot be owned by Sponsors" or whatever wording we use then I am sure it would change very little as CROs in question would just change the corporate setup to escape the issue.

For almost four years I was in a similar situation. The CRO (performing all the good stuff except the clinical part) was an ‘independent’ company though 100% owned by a generic company. Did we care whether a study passed or failed? Of course, not. A failed study is great cause you will get another one. ;-)
My boss (incidentally the nephew of the big boss) tried to convince him to work also for other companies. No way. In 1984 we founded our own CRO. My boss was disinherited. Didn’t regret it.

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