Category Archives: Blog

What a CTA can accomplish for you

My name is Nicole and I am working as a Clinical Trial Assistant (CTA) at [...]

Updated IMDRF guidance on PMCF studies

On 20 May the IMDRF posted an updated guidance on Post-Market Clinical Follow-up (PMCF). Guidance [...]

What are side-effects and what is their relationship to residual risk and adverse events?

We are all familiar with the listings of side-effects in the package insert of medicines [...]

The new ISO14155 standard for Good Clinical Practice is now published!

After many delays it now officially available: the new ISO14155 standard for clinical investigations of [...]

Investigator Initiated Studies, what are they and how can they be of value to your company?

Investigator Initiated Studies (IIS) are clinical investigations that are started by physicians. As opposed to [...]

Clinical data collection during a pandemic; not an impossible task

How to avoid delay and non-compliance of your PMCF activities With full MDR implementation less [...]

How PMCF surveys can help collect clinical evidence remotely during the COVID-19 pandemic

Due to the COVID-19 pandemic many clinical investigations other than those aimed at management of [...]

Health authority responses to the COVID-19 impact on clinical research

The COVID-19 crisis places a huge burden on the healthcare systems of countries around the [...]

Key Opinion leader engagement for your clinical investigation

What can KOLs add to your Clinical Investigation? Key opinion leaders (KOLs) are experts and [...]

The research naïve study site – always a problem?

Your potential investigator / KOL is very enthusiastic to do your study but does not [...]