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Livelink Solution Transforms Regulatory e-Submissions for New Drug and Medical Device Applications
Open Text Corporation, provider of Livelink, the leading collaboration and content management software for the global enterprise, said today 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 millions of pages of documents from multiple submissions.
Applications for regulatory approvals in life sciences have evolved from massive paper document collections submitted all at once, to a rolling, electronic-submissions process requiring ongoing coordination with regulators. The process has grown in complexity despite attempts at simplification such as the adoption by regulators worldwide of a standard format for drug and biological product applications called the Electronic Common Technical Document or eCTD. Rolling submissions require both the regulators and the submitting company to maintain identical document repositories throughout the submission's lifecycle. The challenge is managing changes to information within the company and re-synchronizing those changed documents with those being reviewed by regulatory authorities.
Livelink for Collaborative Submissions offers a single, end-to-end system to manage 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 tightly 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.
“We created Livelink for Collaborative Submissions to offer customers a single platform to manage submissions information and synchronize changes with the multiple regulatory authorities in major global markets,” said Martin Sumner-Smith, Vice President of Pharmaceutical Solutions at Open Text. “It can also manage a far wider range of submission types than any other product, and as such is the first dossier management system for all product-related submissions.” 30.01.2004, Open Text Corporation
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