OpenText Clinicals

Manage all paper and electronic forms and reports through the setup, execution and review of clinical studies

OpenText Clinicals (formerly Livelink ECM -Clinicals) is designed to manage the capture and review of all trial-related information throughout the setup, conduct and review of clinical trials. It is a highly scalable platform already in use by some of the largest pharmaceutical companies and clinical research organizations (CROs) to manage their multiple, global clinical trials, as well as by smaller biotechnology companies and academic research centers. Included features shared with OpenText Regulated Documents enable compliance with good clinical practices (GCP) and the U.S. Food and Drug Administration's 21 CFR Part 11 regulation.

OpenText Clinicals provides a robust repository. Both electronic and paper formats are supported for all documentation, including case report forms (CRFs), data clarification forms (DCF/DQF), study startup documentation, institutional review, and so on. Support is provided for several industry-leading scanning solutions, as well as electronic data capture (EDC) and email. Content is managed in pre-defined information hierarchies that can be automatically created after validation based on incoming material, and which use OpenText Clinicals' advanced category and attribute features to manage the extensive metadata typically associated with each entry.

OpenText Clinicals is also a powerful process management tool, with support for critical formalized processes such as severe adverse event (SAE) responses, medical and safety review, document review and approval, and so on using the solution's robust but flexible workflow and data reporting features. In addition, ad hoc and informal review is facilitated by task management functions, with a range of team collaboration features.

Data entry and review features, including interfaces to clinical data repositories, are available, as are off-line synchronization and data export. Combined with OpenText Eloquent Media Server, the orientation, training and certification of all personnel involved in every aspect of the clinical trial process can be managed and documented. OpenText Clinicals is the first, comprehensive, end-to-end clinical trials management solution!

Features

The key features of OpenText Clinicals includes:

• High-volume capture of paper and electronic documents, records and forms: With support for a range of scanning solutions, customer tests have shown that several hundred thousand scanned documents can be loaded into Clinicals in one week! Some current installations already hold well in excess of 10 million documents! Electronic capture is even easier.
• Automated hierarchy creation, information classification and disposition: When a new document is received, it is identified (indexing information extracted), validated and automatically deposited into the right folder in the system. If that folder does not already exist, it is automatically created and appropriately named.
• Automated generation of casebooks that consolidate all patient-related information: In a long-term study there may be more than a hundred documents associated with just one patient. Clinicals makes review of this material much easier by automatically publishing a consolidated casebook for each patient in PDF format, with the sections organized by visit and domain, and easy navigation through bookmarks. Reviewers need only access the most current casebook, which is automatically generated.
• Streamlined, role-based interfaces: User interfaces are tuned to meet each of the key roles involved in the overall trial management process to facilitate efficiency and user acceptance.
• Process management through workflow, reports and notification: Clinicals provides a range of collaborative and business process management features that can be used to manage informal ad hoc processes as well as carefully managed and sequenced workflows. Clinicals' notification features let users individually determine what events they need to be told about and how often, in addition to pushed user notification of critical events.
• Support for electronic signatures and signing processes: Using Clinicals' electronic signature capabilities, key documents and forms can be electronically signed by approvers in a manner that complies with the FDA's 21 CFR Part 11 regulations and comparable regulations of other pharmaceutical and life sciences regulatory agencies.
• Support for data entry into clinical databases: While Clinicals is the ideal environment to manage all of the materials generated through trials, and to manage trial processes and team work, data must be extracted and exported to a clinical data repository, such as Oracle Clinical or Phase Forward Clintrial.
• User training and certification options: Combined with Eloquent Media Server, the orientation, training and certification of all personnel involved in every aspect of the clinical trial process can be managed and documented.