Understanding the role of a marketing authorisation holder in the regulatory submission process
In clinical research and drug development, regulatory submissions are [...]
The future of the rare disease landscape and the value of CRO support in this specialist area
The World Health Organization (WHO) defines a rare disease [...]
FDA provides new guidance on conducting clinical trials with decentralised elements
Clinical studies have traditionally required participants to come to [...]
How to get an EMA marketing authorisation
Obtaining marketing authorisation in Europe can be a complex [...]
Getting an orphan drug marketing authorisation in the European Union
Thanks to its large population and well-established healthcare system, [...]
Why TMC is more than just a CRO
What is a clinical research organisation? By definition, a [...]
The role of pharmacovigilance in oncology drug trials
Some of our experts recently penned a thought-provoking article [...]