harmonisation

Digital

How to deal with fragmented data - A $12.9 million challenge

In the age of AI, large data sets – like the treasure trove of customer data most biopharma companies are sitting on – are an invaluable asset.

R&D

Planning strategies for transitioning to the Clinical Trials...

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive1 to the Clini

R&D

A clearer harmony and attractiveness for EU Clinical Trials ...

EU Clinical Trials Regulation (EU CTR) has been a hot topic for a little while now.

Market Access

A strategic approach to local affiliates in the global era

While global harmonisation remains the holy grail, the reality is that pharmaceutical companies still face significant challenges navigating regulatory differences.

News

Alliance eyes European 'single market' for digital therapeut...

There's a growing body of evidence that digital therapeutics (DTx) can complement other therapies for a wide range of health conditions, reducing costs and improving patient engagement, but

News

Digital health body publishes best practice guide for DTx de...

Companies trying to bring digital therapeutic (DTx) products through development and into the market have been navigating in largely uncharted waters for years.