Safety Management Plan (SMP) Development

The safety management plan (SMP) is one of the foremost pivotal document that states all safety communications between the sponsor and the CRO. SMP enlists roles, responsibilities, processes, and timelines for all safety activities.

It enables thorough monitoring and early detection of risks/issues in the clinical trial to help enhance patient safety. We help you chart a systematic plan that not only identifies the key risks, issues and mitigates them but also ensures that all the safety data is carefuly documented and processed.

Partnering Throughout the Product Lifecycle

We believe in planning ahead thus we help you create SMP including Development risk management plan, safety monitoring plan and other relevant postmarketing safety documents. We work closely with you and identify probable compliance gaps and create efficient strategies to manage them.

We keep abreast with the latest technologies and proud ourselves to use state-of-the-art tools and systems to proactively handle pre and post clinical safety surveillance activities throughout the drug development lifecycle.