Automate Clinical Study Reports
with reusable clinical content and data analytics

Clinical Study Reports (CSR)

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.

Key Features

Manage end-to-end clinical study reporting process including planning, report authoring and distribution
Estimate resource and budget needs based on upcoming submissions and approvals.
Generate reporting obligations worldwide based on studies portfolio
Collaborate with other departments, partners and local affiliates
Optimize reporting plans utilizing harmonization strategies to reduce total overall reports
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 planning and scheduling of Clinical Study Reports worldwide

Automate collaborative authoring of Clinical Study Reports (CSR)

Configuration tailored to organization internal standards and external regulations

Seamlessly integrate with existing systems such as EDC, CTMS and others

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

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