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info@atvigilx.com

Safety Management Plan

Safety Management Plan outlines strategies for monitoring, assessing, & managing safety concerns throughout a product's lifecycle or clinical trial. At Atvigilx, we tailor Safety Management Plans to each project's unique needs. Our plans include comprehensive risk assessment methodologies, detailed safety monitoring protocols, & clear escalation procedures. We ensure proactive identification of potential safety issues & implement effective risk mitigation strategies.

Customized Safety Management Plan

Development and implementation of a tailored safety management plan based on specific company and compound needs for effective risk mitigation and compliance.
Tailored to specific company & compound requirements
Comprehensive safety protocols and procedures
Effective risk mitigation strategies
Regular review and updates
Safety Management Plan
Safety Management Plan

Importance

Defines roles, ensures clear communication, and manages regulatory compliance while prioritizing patient safety in clinical safety management.
Safety Management Plan

Framework

Manage safety report collection, review, follow-up, unblinding, reporting, distribution, delegation, breaches, deviations, & benefit-risk assessment effectively.
Safety Management Plan

Development and Review

Experts collaborate with sponsors to identify stakeholders, collate SMP content, disseminate for review, and update continuously with new safety information.