No-one would deny that DCTs are currently the very height of fashion; we take a wry but informative look at this important trend and suggest that vendors should perhaps be a little less self-congratulatory!

There’s no doubt that MDR may impact on the continued viability of many devices in the EU market. Mores studies will be required – and far more ongoing post market surveillance will become the norm. EDC will support PMS at a significantly reduced cost.

What factors are key to understanding when choosing to use a subject’s own device is a better way of gathering data directly rather than providing devices for the purpose?

The recent changes to the IVDR timeline are welcome – but there’s no room for complacency or delay.

For many, working with expert partners to deliver compliant studies is an unavoidable – and expensive – fact of life. What are the options open to the smaller company, in particular? How do you decide what’s best for your company?

There is no shortage of vendors in the market, all offering subtly different features, functions and support packages – with a plethora of pricing plans which can vary massively in overall cost. What are the key questions you need to ask when choosing an EDC system that will be right for your company?

How do ensure you are getting the best value for your company? What do you need to ask a prospective vendor to ensure that you can fully understand what the costs will be – and that they are competitive?

For many smaller companies, EDC may not seem to be an urgent consideration. The benefits of digitization extend way the beyond more efficient collection, recording and analysis of study data; these advantages can be exploited by all, regardless of size.

In this fresh take on the age-old paper v EDC debate, we make the business case for eClinical solutions

A guide to the current market situation and requirements driven by the MDR regulations.