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.
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.
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.
Our Clinical Safety services – in detail.
- SUSAR & SAE intake, processing, reconciliation, and reporting.
- Perform Analysis of Similar Events (AOSE).
- Generation of Monthly Case Line Listings.
- Provision and management of the safety database (Veeva Vault).
- DSUR preparation and submission.
- Local Clinical Regulatory Intelligence gathering and triage.
- SPOR and EudraVigilance registration.
What our clients say about us.
I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.
Thank you very much to you all involved recently providing the necessary additional audit documents requested by the authorities. Your support was instrumental in successfully finalizing a process that started back in February.
Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire.
Case studies.
