Safety Management Monitoring Plan

Safety Management/Monitoring Plan.

Creating the path to trial safety, through planning.

Our clinical safety 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.

Our safety management approach is described in your safety management/monitoring plan.

We can prepare and review your safety management plan, with all associated forms, including business contingency planning for Serious Adverse Event (SAE)/ Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting, to manage all your trial drug safety information. 

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 the development portfolio.

Selected PV Case Studies.

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ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
Local PV, regulatory strategy
Complex pharmacovigilance local support

What our clients say about us.