Clinical Study Reports

Clinical Study Reports scheduling, authoring and distribution 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 and harmonization initiatives further complicates the overall end-to-end reporting processes. Changing regulations in different countries, new studies and resource turn-over introduces tremendous challenges to organizations to ensure global regulatory commitments to agencies are met in time. The lack of centralized system or knowledge base does not offer capabilities to optimize worldwide reporting thereby increasing the overall number of reports. This increases the cost and resource needs within organizations.

Quartica’s solution can help manage the end-to-end process clinical study reporting process from scheduling to distribution and tracking of compliance metrics. The solution integrates protocol optimization, assessment, planning, and analytics and internal company processes to provide a centralized system. It provides automated, agile and proactive tools to organizations by reducing overall reports and ensuring regulatory commitments are met on time in a cost effective manner.