My name is Nicole and I am working as a Clinical Trial Assistant (CTA) at [...]
On 20 May the IMDRF posted an updated guidance on Post-Market Clinical Follow-up (PMCF). Guidance [...]
We are all familiar with the listings of side-effects in the package insert of medicines [...]
After many delays it now officially available: the new ISO14155 standard for clinical investigations of [...]
Investigator Initiated Studies (IIS) are clinical investigations that are started by physicians. As opposed to [...]
How to avoid delay and non-compliance of your PMCF activities With full MDR implementation less [...]
Due to the COVID-19 pandemic many clinical investigations other than those aimed at management of [...]
The COVID-19 crisis places a huge burden on the healthcare systems of countries around the [...]
What can KOLs add to your Clinical Investigation? Key opinion leaders (KOLs) are experts and [...]
Your potential investigator / KOL is very enthusiastic to do your study but does not [...]
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