Signal and Benefit-Risk Management.
Managing your Signal Detection and Benefit-Risk profiles to ensure patient safety.
You can rely on our experience and expertise to manage the Signal Detection and Benefit-Risk profile of all your investigational and marketed medicinal products. Our experts have the in-depth knowledge to support the Signal Detection and Benefit-Risk oversight for your products, optimize your patients’ safety and the compliance of your PV system.
There is no one-size-fits all solution to signal management and our approach is tailored to your needs to ensure that signals are detected and managed. Detected signals undergo Validation, Prioritization, and Assessment in a manner that ensures continued patient safety. You will be regularly informed about the process and involved in the decision-making via the Drug Safety Committee meetings held at agreed intervals and involving the mandatory stakeholders – such as the QPPV, Safety physicians, client and Arriello representatives.
We provide full consultancy on navigating the regulatory landscape from the planning stages of your trial through to the MA application and the full product lifecycle requirements beyond.
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.
