Open Text Corporation said it is introducing a new solution that gives life sciences companies a single, unified environment for managing the complex 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 documents from multiple submissions. Livelink for Collaborative Submissions offers a single system to manage eCTD-compliant submissions to the FDA, the European Agency for the Evaluation of Medicinal Products (EMEA), and other regulators. 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 tightly sequenced workflows. Integrated tools such as check-in/out, version history, event auditing, signing controls, alternate renditions and compound documents help manage documents, their constituent documents and related components. The product is being deployed in pilot customer sites and will be released in Spring 2004. www.opentext.com

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