Report study results or face a big stick: the pros of regulatory penalties

Reporting your clinical trial results is both a legal requirement and a moral imperative. Whether your product failed early on, failed in later-stage trials, or was successful, the data from those trials could be transformational. Until recently, though, companies faced few consequences if they didn’t report their results. In April 2021, the FDA threatened to […]

Independent Oversight: Why It’s a Risk to Have Your CRO as Your Legal Representative

In theory, there is no reason and nothing in the Clinical Trial Regulation (CTR) that prevents a contract research organisation (CRO) being named as the EU Legal Representative by a Sponsor. However, it does beg the question as to whether there would be a conflict of interest, since what it means is the sponsor is […]

The QA to the Sponsor’s QA: Why the Legal Representative Should be Separate from the CRO

The role of the legal representative for clinical studies – both in pharmaceuticals and now in medical devices under the EU Medical Devices Regulation (MDR) – might be described as quality assurance of the sponsor’s QA role. In future, under the new EU Clinical Trials Regulation (CTR) and MDR, the legal representative will be responsible […]

Why “Ensuring” the Sponsor’s Compliance is Not the Right Role for CROs

The Medical Devices Regulation will bring massive and rapid change to the industry. Not only must companies adjust to new clinical investigation requirements, but they will suddenly find themselves in need of a number of new experts. Medical device companies wanting to run clinical investigations of their products in Europe will need a qualified person […]