Safety Management Plan (SMP) Development

Creating the Most Effective Plan to Ensure Safety

The Safety Management Plan (SMP) is one of the most important documents because it regulates all safety communication between the Sponsor and the Contract Research Organizations (CROs). The SMP details the roles, responsibilities, processes, and timelines for all safety activities. It ensures a systematic approach to safety monitoring and promotes early issue detection to help mitigate any safety risks in clinical trial subjects and patients.

The experts at ProPharma Group help you create a plan in a form that represents the key safety activities identified by the sponsor. The SMP serves as a strategic document to ensure all safety data during the clinical trial are accumulated and processed in a systematic manner.

Partnering Throughout the Product Lifecycle

At ProPharma Group, we partner with you to create an SMP document that includes a Development Risk Management Plan, Safety Monitoring Plan, and other postmarketing safety documents. We work together with your team to minimize compliance gaps and to create efficiencies in managing your safety data.

Our experts follow the latest industry trends requiring a more proactive approach to pre- and post-clinical safety surveillance activities to ensure patient safety throughout the drug development lifecycle.

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Need Help Managing Your Drug Safety Requirements?

Contact us to learn how our clinical and postmarketing PV services can support your needs on a standalone basis or integrated with global Medical Information and Regulatory services.

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