Our client, an international clinical research organization (CRO) within a leading health management company, was using physical folders to store and manage critical paper study documents while conducting clinical trials for their various pharmaceutical sponsors. Trial documentation was accessible from three regional centers, but often, documents were dispersed in local duplicate “shadow” files. If a study team member or auditor needed to view a study’s documentation, they had to travel to one of the regional centers or request copies. Because of the distributed nature of clinical trials, their physical storage system faced many challenges that became unmanageable, increased risks of ensuring access to current document versions, and was costly to package and deliver completed study files back to sponsors.
The client sought to replace their existing paper-based Trial Master File (TMF) with an electronic TMF Document Management solution to achieve the following benefits:
Their desired solution was a validated, easily accessible, web-based Document Management platform organized in a standard but customizable hierarchy with secure document submittal via scanning, email and import. The client also wanted the platform to be easily expandable in the future to include Asia Pacific regions and support electronic medical authoring and submissions.
ArborSys collaborated with the client’s key business and IT representatives to design, develop, and implement an enterprise-wide document management system that met the client’s clinical trial documentation storage needs across their research and statistical organizations globally. ArborSys conducted requirements gathering and business process workshops with each global business area responsible for project management, field monitoring, regulatory affairs, data management, quality assurance, and document storage to document and standardize their study lifecycle processes. The design was verified interactively with the client via system prototyping and reviews. The system included a customized User Interface (UI) and was customized to ingest study email and attachments directly to specific studies and export searchable text-based PDF documents from the scanning application via their metadata. After the development and validation of the system was completed, ArborSys developed classroom and computer-based training materials and worked interactively with the client to deliver the training globally to key users.
EMC Documentum’s content management repository and WebTop UI was configured and customized along with EMC’s Business Process Services (BPS) to provide email integration. Captiva InputAccel was customized to support scanning and integration of scanned documents into the repository.
The ArborSys team was engaged to:
The following diagram illustrates the process flow for the electronic TMF system:
Our team was able to design and deliver a solution that met the clients’ current needs and supported their future initiatives. The electronic TMF solution provided a standardized yet global platform for the management of all clinical trials that:
The implemented architecture was expandable to support incremental scanning and document storage to additional Asia Pacific regions, and provided a flexible foundation for future authoring and submissions functionality.
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