The issue

If you'd like to conduct a clinical trial, first of all, you need to evaluate whether it is feasible or not.

Often this is done via CROs with assumption that it has expertise, access to HCPs network across countries and regions.

Once done, often the same CRO get either in full or part study execution contract.

However, in such case, we believe, there is a clear conflict of interest: CRO often intentionally 'improves' feasibility results in some or all aspects (i.e., regulatory and recruitment timelines, patient journey and accesss to required study population, healthcare infrastructure, equipment and investigator's experience, finally, national treatment guidelines and routine practices).

The idea behind is simple- let's get the deal done with the sponsor, and then we'll manage the expectations.

As a result, too optimistic timelines, unmet expectations for the overall study conduct, high cost and delay in marketing authorisation.