Global and Local Pharmacovigilance Services, since 2008

Signal and Benefit-Risk Management.

How we manage your benefit-risk profiles and ensure patient safety.

You can rely on our experience and expertise to manage the benefit-risk profile of all your investigational and marketed medicinal products, including Signal Management. Our experts have the in-depth knowledge you need to keep your patients safe and stay compliant with legislative requirements.

There is no one-size-fits all solution to signal management and our approach is customized to your needs to ensure that signals are detected at the right stage. Signals undergo validation, prioritization, and are then assessed 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 – 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 marketing authorization application and the full product lifecycle requirements beyond.