The 5W1H Approach toWriting a Clinical Study Protocol An age-old writing methodology based upon the thoughts of Aristotle, the Ancient Greek philosopher and scientist who was Plato´s student and who later taught Alexander the Great, is as applicable to today´s technologically advanced biopharmaceutical research sector as it has been throughout history. This 5W1H formula constitutes […]



The CTD Pyramid Around the turn of the century, the Common Technical Document (CTD) became the standard reporting format that needs to be followed when submitting data on the quality, safety, and efficacy of a treatment for all new drug applications (NDAs). The CTD is a mandatory reporting format in the EU and Japan and […]



Finding the art in medical device compliance Notified Bodies need to evaluate the medical device´s operating risk-benefit ratio and various other factors and, in order for them to do so, the MDR 2017/745 and the MEDDEV 2.7.1 (Rev 4) states that they require a description of the “state of the art” in the medical field associated with […]



Crafting an Effective Clinical Evaluation Plan The MEDDEV 2.7.1 (Rev 4) introduced the requirement of a Clinical Evaluation Plan (CEP) and the Medical Device Regulation (MDR 2017/745) gave more details on what this new and critical document should contain (particularly in Annex XIV, Part A). The scope of the full clinical evaluation is stated in the CEP and includes, at the very […]



Writing a Successful Clinical Evaluation Report As medical device companies work toward complying with the more stringent medical device regulations and guidelines, the role of effective medical writing becomes increasingly important. Central to being compliant with the new Clinical Evaluation requirements is the development of novel documents, including the Clinical Evaluation Report (CER). The fourth […]








Message from the Europital CEO

To our Clients, Staff and Partners

Since the reporting of first cases of COVID-19 infection, Europital management has kept a close eye on the evolvement of this novel virus and continuously assessed the risk associated with the spread of infection in other parts of the world...  [read more]