It's also worth noting that the parent claim of unclear compliance guidelines is less of a statement of fact and more a commentary on your average pharma industry lawyer. There are more suites of standardized compliance applications than you could shake a stick at, that's not at issue. The problems usually start with a department of contract lawyers who can't be assed to skill up on industry specifics. Throw in a CFO with little or no experience managing CRO's and you've got the perfect recipe to get dumped on by the OIG.