Responsible Person services.
The right skills. The right experience. The right person.
For a sponsor, who is not a Marketing Authorization Holder (MAH) or Applicant, an organization’s representative for the EudraVigilance registration process (a Responsible Person for EudraVigilance) must be appointed.
One Responsible Person for EudraVigilance is appointed by a sponsor for all their clinical trials conducted in the EEA.
We can provide you with a standalone Responsible Person allocated to your project.
Selected PV Case Studies.View all
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.