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 […]

 

 

So Many Documents, So Little Time In each stage of clinical development, everybody needs to be sure that drugs are both safe and effective. This is mainly achieved by analysing the documents that report these two factors and which have been expertly synthesised throughout the initial registration and clinical trial cycle. There are many documents […]

 

 

Compassionate Use – help is at hand! When all approved therapies have been exhausted and no satisfactory or alternative therapy options remain for a patient with a serious or immediately life-threatening medical condition, the patient’s last path available could be to use an unapproved treatment. Receiving this treatment without participating in a specific clinical trial […]

 

 

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 […]