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 […]

You have options! Your study may not need a full CSR for your marketing application. Depending on the type of study you are conducting, or its intended purpose, it may only be necessary to submit an abbreviated version of the full ICH E3 CSR. The FDA and EMA have produced a series of guidelines and legislation aimed at clarifying […]

Regulatory reporting of IVD Performance The In Vitro Diagnostic Medical Device Regulation (IVDR), set to be in full force by 2022, outlines a variety of reports that must be written to demonstrate the scientific validity, analytical performance, and clinical performance of the IVD. The nature and extent of the IVD’s scientific validity is to be documented in the scientific validity […]

The many changes to IVD regulations There has been a comprehensive upgrade in European medical device legislation for in vitro diagnostics that reflects the technological advances that have been made since the industry’s previous regulations were introduced more than 20 years ago. The new In Vitro Diagnostic Medical Device Regulation (IVDR) is not just a little […]

Europital’s Everyday Ethics The emphasis we put on delivering the highest quality of clinical evidence, and the necessity of a scientifically rigorous approach to clinical trial planning and data review, ensures that each trial we work on has the optimum outcome for the potential treatment’s future patients. It is for this reason that sponsors return […]

With or Without a Medical Writer? The publication of clinical trial results need to be reported in a high quality, comprehensive, and timely manner in order to share useful research findings with the global community. This enables efficient worldwide clinical development and allows both clinicians and patients alike to judge the risks and benefits of […]