Clinical Safety Management Plan.
What is a clinical Safety Management Plan?
Throughout the development phase of a medicinal product, the Safety Management Plan (SMP) is a critical document used by clinical trial sponsors to minimize the risks for trial subjects and patients.
The primary function of the SMP is to define the roles, responsibilities, processes and timelines of all the stakeholders involved with the safety activities of the trial.
The SMP links together Sponsor, CRO/PV Service providers, Safety Database provider, and any other parties, outlining who is responsible for what during the trial, including details on narrative writing, triage and reportability, unblinding and importantly, the handling of SAE’s and SUSARs.
Why choose Arriello for your clinical drug safety?
Our clinical trial consultants can advise you on the best way to set up the safety management of your trial, taking into consideration the study phase, indication, subject, other parties involved in the trial execution, and budget.
We can prepare, or review, your Safety Management Plan, with all associated forms including for Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) Pregnancy Notification/Outcome, and Adverse Events of Special Interest (AESI) reporting, to manage all your trial drug safety reporting requirements.
We can maximize the value of the clinical safety services we offer when those services are applied not just to a single trial, but when we partner with you at a strategic level, and work with you across your development portfolio.
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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.