Signal and Benefit-Risk Management.

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.