Structured Clinical Authoring
with Content Reusability
across clinical documents

Clinical Protocol & Related Documents

The linear and siloed nature of the Clinical Document Authoring process limits seamless connectivity, transparency, accessibility, and innovation. This can result in individual point solutions, disparate manual processes and data, localized learnings, and most importantly, considerable time inefficiencies, especially with increased trial complexities. Traditional structured content authoring approaches while innovative do not provide the robust capabilities to streamline protocol optimization, assessment, planning, and analytics.  The combination of localized tools, manual steps and knowledge base from individual resources results in lack of centralization of protocol information as well as the schedule of assessments for the majority studies. The current processes are also sequential and linear and do not support parallel activities and co-authoring making the overall process time consuming and inefficient.

Quartica’s MARS based AI solution delivers an innovative structured clinical authoring solution and framework for further scaling of clinical development upstream and downstream systems. The solution supports incorporation and maintenance of clinical authoring digital content that can be used multiple times in different contexts for multiple assets, therapeutic areas, within clinical documents , such as Clinical Trial Protocol document, Clinical Trial Protocol Amendment, Informed Consent Form (ICF) and others. It supports seamless flow of content and information between upstream and dependent downstream systems. The AI based protocol authoring solution supports a standards-driven approach with ability to reuse content while collaborating to generate documents such as protocol, protocol amendment and Informed Consent documents.

Key Features

Manage end-to-end clinical authoring process including planning, authoring,review, and publishing
Automate the reusability of content between clinical documents
Optimize workflow management and productivity to support parallel activities and real time co-authoring
Centrally manage protocol information and schedule of assessments for studies
Ensure conformance to clinical authoring standards, templates and regulations.
Seamless flow of content between upstream systems and downstream systems.
Collaborate with other departments, partners and local affiliates
Track decision log, review and approval history for complete traceability
Support for protocol optimization, assessment, planning, and analytics

Benefits

Content Reusability in different contexts for multiple assets and therapeutic areas

Automated structured content authoring aligned with overall industry clinical data standards

Workflow management to support parallel activities and real time co-authoring

Seamless flow of content and information between upstream and downstream systems

Ready to automate your Clinical Safety reporting process?

Scroll to Top