Open Text Corporation, provider of Livelink, a collaboration and knowledge management software for the enterprise, has announced two new Livelink solutions designed to help pharmaceutical companies manage the volumes of documents, reports, and other information generated as companies develop and gain approval on new drugs. The solutions, Livelink for Regulated Documents and Livelink for Clinicals, are designed to offer uniform electronic processes to help ensure compliance with rules from regulatory authorities, including the U.S. Food and Drug Administration (FDA).
Livelink for Regulated Documents gives pharmaceutical companies end-to-end lifecycle support for the large volumes of reports and other documents created during the discovery, development, testing and approval processes for new products. The solution is designed to carefully manage critical documents for drug research and development through a lifecycle, which includes document authoring, reviews, approvals, and dissemination.
Livelink for Clinicals is designed to help pharmaceutical companies reduce costs and improve accuracy, while speeding the time to "data lock," the point at which clinical trials can be closed and researchers can begin to assess results. Livelink for Clinicals automates the process for coordinating and maintaining all required regulatory documentation, such as detailed contracts with each clinical trial site, informed consent forms from the trial subjects, and credentials of all investigators participating in the study. During clinical trials, Livelink for Clinicals improves the Case Report Forms (CRF) tracking process. CRFs detail how individual patients react to a new drug. Livelink for Clinicals lets research staff scan reports and store each as an image in Livelink, making them easier to search and retrieve. Livelink for Clinicals also automatically generates casebooks of reports by assembling and indexing CRF images into a single document, with links so that it can be navigated. Livelink for Clinicals also helps researchers manage information for Severe Adverse Event (SAE) forms, which detail adverse reactions to new drugs among patients in a trial. When SAE documents are scanned or faxed in, Livelink for Clinicals allows researchers to maintain all records for an SAE, as well as incorporate detailed workflows to coordinate, track, and ensure a fast response, for example, warning other clinical trial sites and the appropriate regulatory agencies.