Clinical Safety 2022

Clinical Safety Overview.

Why choose Arriello?

At Arriello our ethos is not to simply be your service provider but to act as your Pharmacovigilance (PV) Department and an extension of your business.

We believe that project delivery should go beyond the provision of services but bring with it our extensive knowledge, experience and expertise to not only support the immediate active studies but anticipate future planning as scalability as your program expands.

Our team have a global footprint and our clinical safety services are underpinned by a robust regulatory intelligence framework enabling us to anticipate and proactively manage changes in regulation throughout your clinical safety program.

Our team of trusted experts have a wealth of experience in the management of clinical safety and are very aware that no two study programs are alike. 

Regardless of study phase or size, every program will have a unique set of challenges and require a bespoke solution.

For all of our clinical safety programs we take a holistic approach to set up and study management, we are aware that our clinical safety projects have multiple stakeholders and each of their needs must be considered in the solutions we provide. Good communication is critical to project success.

When it comes to the provision of clinical safety services, we are aware that the information collected in your clinical safety program is your data that you have entrusted us to manage and that it will underpin the safety decision making and information for the rest of the product’s lifecycle.

Our clinical safety team will ensure our database is set up to enable you to access your data and our robust case processing conventions and standards will ensure consistency to support both your immediate study program needs as well as future assessment and review. 

This means that as you build the product’s benefit: risk profile and your Development Risk Management Plan (DRMP) the data will be processed and coded in a way that facilitates assessment.

Ready to contact us?

Our approach to managing any project is proactive and flexible, taking responsibility for ensuring high quality safety data to support signal detection, benefit: risk assessment, global regulatory compliance for expedited (SUSAR) and aggregate (DSUR and ASR) reporting and efficient communication of safety data. We are used to managing clinical safety projects with multiple stakeholders and our safety database is designed to facilitate cross reporting and streamlined communication across multiple parties including IRBs, Ethics and Safety Monitoring Committees as well as partners.

Throughout the project we will provide consultancy and guidance where needed, ongoing regulatory intelligence updates and impact assessments and a clear framework and transition plan, so our clients have all the information needed to ensure successful outcomes for their clinical safety programs. 

Additionally, we can also support activities as the clinical program reaches its conclusion including support for Expanded Access Programs (EAP) and product licence application and approval.

We operate across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.

The number of countries we operate in.
Partner/Vendors in our audited network.

What our clients say about us.

Case studies.

ICSRs, Local literature screening, Regulatory intelligence
Strategic planning for effective results.
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system.
Local PV, regulatory strategy
23 Countries in two months.
Pharmacovigilance system, Europe, Local and global PV
EU expertise delivers results.