Safety management plan
The safety management plan (SMP) represents a critical document pertaining to the overall operational conduct of a clinical trial and helps the sponsors to systematically identify, assess, and manage the SAEs and SUSARs associated with their therapies to ensure patient safety remains the top priority.
Development and implementation of a robust safety management plan based on individual company and compound needs.
Importance
A comprehensive SMP defines roles and responsibilities of all stakeholders including sponsors, CROs, and PV provider, with clear communication and collaboration channels to manage regulatory expectations and compliance without compromising patient safety.
Framework
Address initiation and termination of collection of safety reports, review, follow-up, unblinding, reporting to authorities, distribution to stakeholders, delegation of safety responsibilities, management of breaches and deviations, and continuous benefit-risk assessment.
Development and review
Our experts work closely with the sponsor to identify stakeholders responsible for contributing SMP development, collate content, disseminate for review, and continually update it as new safety information becomes available.