Safety Management Plan (SMP) and Investigator Brochure (IB)
Clinical Safety
The Safety Management Plan (SMP) is a critical document outlining the strategy and activities to monitor and manage the safety of investigational medicinal products during clinical development.
The Investigator Brochure (IB) provides comprehensive clinical and safety information about the investigational product to investigators and ethics committees, ensuring informed decision-making and patient safety.
PVpharm offers expert services for the preparation, review, and maintenance of SMPs and IBs, ensuring alignment with regulatory expectations and best practices.
Our services include:
- Creation and updating of SMPs: tailored to your clinical trial protocols and regulatory requirements
- Development and thorough review of IBs: to include up-to-date safety data, risk assessments, and clinical information
- Safety signals integration: inclusion of emerging safety signals and new data into the SMP and IB throughout the clinical development lifecycle
- SMP management: Coordination with clinical teams and regulatory bodies to ensure compliance and transparency
- Document readiness: Ensuring that SMPs and IBs are audit-ready and support clear safety communication with investigators and Regulatory Authorities.
