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.
Developing SMPs for Pharmacovigilance
Safety management plans (SMP) are foundational documents to describe the conduct and monitoring of PV activities during a clinical trial to ensure patient safety and regulatory compliance.
At Qinecsa, we create robust, compliant SMPs that meet the essential standards and your specific needs. Each SMP includes:
- Clear safety objectives and governance procedures
- Clear roles and responsibilities of all stakeholders
- Regulatory compliance and timely reporting
- Reporting timelines and mechanisms
- Structured and standardised processes
- Training and communications
Regulatory Alignment and Best Practices
Our team will create SMPs that satisfy regulatory requirements while implementing industry best practices. This dual focus ensures your organisation maintains compliance and increases patient safety outcomes through practical measures.
Qinecsa’s team of professionals view the SMP as a living document that evolves alongside your priorities. Our approach ensures that product safety considerations remain integrated throughout the development, implementation, and ongoing maintenance phases.
We also recognise that safety management doesn’t exist in isolation. Our plans integrate seamlessly with your existing quality management systems, risk registers, and operational procedures to create a cohesive approach.
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.
Working with Qinecsa for Your SMP Needs
At Qinecsa, we prioritise knowledge transfer, ensuring your organisation builds internal capability alongside compliance. Whether you need a comprehensive plan for a new system or a review of existing documentation, our collaborative process provides you with the support you need to maintain and advance clinical safety governance.
