Automate Safety Management Plan (SMP)
processes within your organization

Safety Management Plan (SMP)

Safety Management Plan authoring, management and assembly processes within organizations have been fairly ad-hoc, linear and rigid utilizing a combination of localized tools, manual steps and knowledge base from individual resources. The complexity of new regulatory standards, individualized local country requirements further complicates the overall end-to-end reporting processes. Changing regulations in different countries, new trial registrations introduces tremendous challenges to organizations to ensure global regulatory commitments to agencies are met in time. This increases the cost and resource needs within organizations.

Quartica’s solution can help manage the end-to-end safety management plan from planning to distribution and tracking of compliance metrics. The solution integrates regulatory knowledge base, company study portfolio and internal company processes to provide a centralized system. It provides automated, agile and proactive tools to organizations by ensuring regulatory commitments are met on time in a cost effective manner.

Key Features

Manage end-to-end SMP process including planning, scheduling, report authoring and compliance tracking
Estimate resource and budget needs based on upcoming trials and needs
Generate compliance obligations worldwide based on study portfolio
Collaborate with other departments, partners and local affiliates
Optimize workflow management and productivity to support parallel activities
Track decision log, review and approval history for complete traceability
Manage Review and Approval workflow process
Configure organizational specific strategies to fine tune reporting plans
Ensure conformance to standards, templates and regulations

Benefits

Automate generation of semi annual safety report schedule and planning worldwide

Automate authoring of semi annual clinical safety reports e.g. (SASR, SASR LL, Clinical SAE LL etc.)

Configuration tailored to organization internal standards (SOPs, templates, format, style, etc.) and external regulations

Support for integration with existing systems such as EDMS, CTMS and others

Automation tailored for the specific regulatory & validation needs of the life sciences industry

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