Literature Monitoring.
Patient safety means we’re always watching, everywhere.
What are Global Literature Monitoring and Local Literature Monitoring?
Global Literature Monitoring (GLM) of indexed journals through systems like Embase® and Medline®, and Local Literature Monitoring (LLM) of non-indexed local journals, are a key element of any pharmacovigilance system for identifying case reports (ICSRs) and new information from various clinical and non-clinical studies that are relevant to drug safety and efficacy.
Literature Monitoring is more than just a regulatory obligation at Arriello because it provides early insight into safety issues and supports the creation of safety and aggregate reports. It also supports the signal management process, and influences decisions that inform the benefit-risk profile of your product, ultimately helping to protect your patients.
Our Literature Monitoring service.
Arriello provides a complete Literature Monitoring service, including the monitoring of the EMA’s Medical Literature Monitoring (MLM) service, with full text review and assessment of safety information.
Our extensive experience in developing robust, search strategies and the construction of optimized literature queries allows us to search for published studies and information specifically relevant to the safety of your products.
We ensure the efficient assessment and auditable results documentation of any information that may impact study subject safety or require further investigation according to agreed periodicity.
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.
