Europital – CSRs: You Have Options!

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

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 […]

 

 

 

 

 

 

 

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]