Responsible Person services.
Why you need a Responsible Person for Eudravigilance and the EEA?
The EudraVigilance registration process requires the appointment of a Responsible Person for EudraVigilance for all clinical trial sponsors who are not a Marketing Authorization Holder (MAH), or Marketing Authorization Applicant (MAA), to act as their organization’s representative .
We can provide you with an experienced standalone Responsible Person allocated to your project and for all your clinical trials conducted in the EEA.
Selected PV Case Studies.
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What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
