Open Text Corporation. provider of the Livelink collaboration and content management software, annouced that it is introducing a solution developed to give life sciences companies a single, unified environment for managing the process of assembling, approving, releasing, and archiving new drug and medical device applications required to enable human clinical trials and product marketing. Livelink for Collaborative Submissions supports the complete lifecycle of the submissions process, providing tools to exchange information with government regulators, as well as manage and track changes to millions of pages of documents from multiple submissions.
Livelink for Collaborative Submissions offers a single, end-to-end system to manage Electronic Common Technical Document or eCTD-compliant submissions to the U.S. Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other regulators worldwide. The solution combines document, forms, and records management software, content publishing tools, and the ability to automate a wide range of processes, from ad hoc to sequenced workflows. Integrated tools such as check-in/out, version history, event auditing, signing controls, alternate renditions and compound documents make it easy to manage documents, their constituent documents and related components to ensure accuracy.
Other key features of Livelink for Collaborative Submissions include: Simplified access to other file and content systems across the enterprise from Livelink to retrieve documents, data sets, and other content needed in a submission; Uniform, pre-defined taxonomies for organizing submission documents based on the eCTD with flexible extension capabilities; Role-based access controls that tightly regulate access rights and permissions according to the roles of participants in the creation, assembly and publishing of submission documents; Desktop integration so users can drag-and-drop items into Livelink directly from the Windows desktop in online or offline mode, using Microsoft Office, Adobe Acrobat, Windows Explorer, and WebDAV-compliant applications.