After the “Panama Papers”,
the “Poland Papers”.
The Clinical Research Organizations (CROs) have an important role to play in the conduct of clinical studies, among other things they are in particular the guarantors of compliance with the regulations… of all the regulations.
Regarding the current regulations on reimbursements of costs incurred by participants, they do not allow them to be made by a CRO itself, this would be equivalent to a payment made by the sponsor of a clinical study itself.
Some CROs violate these regulations, at least until the authorities take over the case.
Our recent experience on this topic:
While we were talking with a taxi company, the latter sent us two invoices that were overdue. After verification, we found that these invoices did not concern us, they concerned a study carried out in France, by an American CRO (USA) who is not a client.
Where it gets annoying is that these compliant invoices contained the participant’s first and last name, as the law requires for invoices. Of course, the recipient was the CRO… but the people in charge of processing the invoices found it useful to provide the address of the CRO in Poland.
We did not imagine that the taxi had invented the address in Poland. The reimbursement process therefore foresees that the taxi bills are paid by CRO Poland.
Whether the reception and processing take place in Poland or not, this means that the CRO has had access to the personal data of a participant. One can
easily imagine that all the participants in this study were entitled to the same “favourable” treatment…
It is therefore possible to imagine that this process, which according to the regulations is totally illegal, is the usual procedure, which constitutes an ethical scandal and a clear breach of Good Clinical Practices (GCP) and legal texts.
I do not know the volumes of payments processed by the CRO, but they are far from neutral... the multiplication of borders does not solve the problem, only the outsourcing of this process makes it possible to preserve everyone's interests. Admittedly, this has a cost, but it will always cost less than 4% of global turnover...
