Clinical Research – Quo Vadis?
SummaryClinical Research – Quo Vadis?
In recent times we began observing a significant acceleration of technology development which aims at improving the quality and speed of clinical trials as well as lowering the costs of it.It would seem that moving from simple paper digitalization to IoE (Internet of Everything) and Big Data will reduce the demand for qualified on-site CRA workforce.
But will it? And would it completely wipe out the needs?
There are ones who prophesies this is inevitable, but personally, I doubt that. Why, you may ask?
GCP regulation is very clear about it - ICH GCP 5.18.1 (a) states: “The purpose of clinical trial monitoring is to verify that the rights and well-being of human subjects are protected.”
Although today's CRA skillset is far more complex than 10 or 20 years ago, having the sense of this purpose remains unchanged. Here at SRG we constantly observe increasing emphasis on this aspect of candidates experience and abilities expressed by hiring managers all around the world, regardless of the level or the position they are hiring for. Technology will undoubtedly automate the workflow and interactions with the study site. However it will not completely eliminate the need for human intervention and the need for human presence. After all, to paraphrase the saying: the system is as strong as its weakest link - a human. As no matter how sophisticated systems and processes are, without compassionate input and care of skilled professional it will fail to deliver its purpose.
In the rush to deliver faster and cheaper, let’s not forget the essence of clinical research: subjects’ safety and well-being.
This is also our sense of purpose. What’s yours?
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