Safety Management Plan (SMP) Development

Create the Most Precise Plan to Guarantee Safety

​

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

​

The subject matter experts at Gemini Group help you construct a plan in a systematic form that characterizes the key safety activities classified by the sponsor. The SMP functions as a strategic document to ensure all safety data during the clinical trial is collected and processed in a comprehensive and efficient manner.

​

We are your Partners Throughout your Products Lifecycle

​

At Gemini Group, we partner with you to produce an SMP document that includes a Development Risk Management Plan, Safety Monitoring Plan, and other post-marketing safety documents. We work cohesively with your team to minimize compliance risks and gaps.  We aim to increase efficiencies and minimize risks in managing your safety data.

Our subject matter experts (SME’s) follow the newest industry trends demanding a more robust and proactive approach to pre- and post-clinical safety surveillance activities to ensure patient safety throughout the drug development lifecycle.