CT documentation development.
Clinical trial documentation review.
We understand the criticality of having a thorough protocol prior to study initiation, and we can advise you on the best approach to set-up the safety section during protocol writing and finalization.
In addition to your protocol, our clinical safety consultants can provide a full review of your Reference Safety information (in the Investigator’s Brochure), contracts, clinical/final study reports, and other documents.
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.