Drug Safety and Reporting Training.
Why do clinical trials need safety and reporting training?
Throughout the development phase of your medicinal product, it is critical that clinical trial sponsors and associated teams are able to create and follow a proactive managed approach to clinical safety and reporting. To ensure this, having the right training and training materials at study sites and beyond, is a necessary requirement for success.
Why choose Arriello for all your clinical drug safety and reporting training needs?
Our clinical safety consultants can prepare all your trial-specific Pharmacovigilance (PV) training materials and conduct all the applicable training for your personnel at study sites during Investigator Meetings, and also for Site Initiation Visits – especially important for Advanced Therapy Medicinal Products (ATMPs).
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.
Overall, the project team functions more as an extension of my team and less as an outside vendor, which is evident by their investment in the outcome and general performance. Working with the Arriello team has been a joy so far and I am excited to see what comes next.