Y-Prime Technologies, an eClinical products and consulting company of Malvern, Penn., is expanding its suite of eClinical software solutions with Prime Publisher, an easy-to-use concatenation tool that streamlines the content review process and combines multiple data forms into a single, navigable format.
"Prime Publisher offers an integrated, component-based approach to building document content and the flexibility to combine exactly what the reviewer needs to see and comment on," explained Dan Glass, vice president of enterprise content management at Y-Prime. "Focusing reviewers and their feedback in large documents containing multiple pieces of information is crucial to reducing re-work and cycle times. Prime Publisher provides much of the functionality of a full-blown system, while being easier-to-use at a fraction of the cost."
The tool simplifies an arduous process such as reviewing large sections of the eCTD. For example, a Module 2 Quality Overview contains cross-references to information contained in Module 3 Drug Product and Drug Substance Manufacturing and Stability information. A typical Module 3 might contain 200 or more documents for an initial application. Prime Publisher enables an author to select the overview and the relevant Module 3 documents combining them into a single review document. It reduces time spent flipping between submission components during review and approval processes, especially where business processes and supporting technology allows the reviewer/approver to assign workflow outcomes to all documents simultaneously.
Prime Publisher also helps in preparation for clinical study reports to a global audience. The tool allows the author to prepare a modular or component-based report to accommodate regional regulatory differences of information provided.
The tool requires minimal training and integrates with industry-leading EDMS systems or fileshares. It offers the flexibility to select virtual documents and leverage an EDMS clipboard (such as inside Documentum and other Documentum-based applications) and also allows multi-select to easily integrate into existing business practices.
All Y-Prime products are backed by 24/7 U.S.-based support, project management and development capabilities.