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.