Improve Efficiencies and Quality in Clinical Documentation Using Structured Content 

Business Challenges

Pharmaceutical companies produce a vast number of regulatory documents throughout the product development lifecycle, many of which are submitted to health agencies, public databases, or external partners. These documents are highly structured and can be organized into distinct sections, creating opportunities for content reuse. By reusing standard templates, data sets, and text from earlier submissions or related documents, and ensuring traceability to easily automate and propagate content or data changes, companies can streamline the preparation and submission process. This approach accelerates regulatory approvals and improves overall efficiency.

The ArborSys Solution

ArborSys worked closely with our client in the design and development of their enterprise-wide program aimed to improve clinical information management capabilities in order to maximize the value of clinical content and documentation. The program is comprised of three parts: process simplification, services delivery, and tools. Process simplification streamlines and improves processes in the document lifecycle. Services delivery provides new processes and functionality for business users. Tools includes a structured content management (SCM) solution to improve productivity, quality, and decision-making in the management of documents.

The primary goal of structured content management (SCM) is content reuse, which boosts both productivity and quality. The second goal is to enable content publishing in multiple formats, making it faster and more efficient to produce documents across various formats while maintaining high quality. Content components can be reused in the documents, and source content changes processes were implemented to notify downstream document owners and propagate changes made at source to all documents.


ArborSys supported our client’s project team by implementing InteliNotion as the structured content platform for several key clinical documents in the first phase of the project. The Protocol, Statistical Analysis Plan (SAP), and Clinical Study Report (CSR) were structured and configured with reuse policies, and libraries were established for standardized content that could be applied across these documents. Additionally, InteliNotion’s Veeva Connector was integrated to store the generated and authored documents in the Vault at a designated lifecycle stage.

Business Value

By shifting from traditional unstructured content to a structured approach, medical writers have improved and streamlined the creation, review, and approval processes. This transformation has led to increased efficiency and consistency, reducing the risk of errors and enhancing traceability. Moreover, structured content authoring facilitates content reuse across multiple documents, accelerating time to market and ensuring compliance with stringent regulatory requirements. This approach also improves collaboration and review efficiency among teams by locking content that should not be edited and removing the need to review/ comment on pre-approved content.