Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
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Life sciences organizations running clinical trials are challenged to aggregate, reconcile, manage, and control a growing deluge of data from internal and external sources. In addition, clinical development is an increasingly networked and collaborative discipline across companies, which further complicates the data management landscape. These factors, as well as continued pressure to boost clinical program productivity and reduce the cost and risk of clinical trials, are driving a critical need for a new approach to clinical data management and warehousing. Oracle introduced Oracle Health Sciences Data Management Workbench to help meet these needs.
Using Oracle Health Sciences Data Management Workbench, researchers can integrate, reconcile and analyze clinical data faster and more accurately, which automates data load, transform and cleanse processes. As a result, study sponsors can make faster, more informed decisions that improve control, support adaptive studies and accelerate clinical trials and time to market.
● Oracle Health Sciences Data Management Workbench enables health sciences organizations to accelerate clinical studies and boost program productivity while helping to drive down the cost and risk of clinical trials.
● The solution, which is integrated with Oracle Life Sciences Data Hub<http://www.oracle.com/us/products/applications/health-sciences/e-clinical/data-hub/index.html>, automatically aggregates, integrates and reconciles the rapidly growing volume of data that clinical trials collect from internal and external data sources, including electronic data capture, laboratory, safety/pharmacovigilance, and drug supply systems. By doing so, it helps dramatically decrease the complexity of data management and reduce the cost of clinical trials.
● In addition, the solution automates the normalization and transformation of multi-source data to create a single source of truth for all stakeholders in the clinical development process and helps enable rapid analysis to drive faster, more informed decisions.
● By providing this standardized data transformation, Oracle Health Sciences Data Management Workbench helps significantly increase efficiency by enabling researchers to pool data from multiple studies for program development and submission.
● Also, by increasing data integration and standardizing data formats throughout the study process, Oracle Health Sciences Data Management Workbench automates the identification and correction of discrepancies in multi-source data that can jeopardize the validity of a study. As a result, the solution helps reduce costs and accelerate database lock.
● The standardized data formats used within the system are repeatable and reusable, which reduces the time and cost of trial set-up.
● Using Oracle Health Sciences Data Management Workbench, organizations can also streamline compliance thanks to full traceability of data discrepancies as well as comprehensive security and audit trail capabilities.
● Focused on helping health sciences organizations of all sizes create clinical trial management environments that increase efficiency and can scale with their needs, Oracle Health Sciences Data Management Workbench integrates with Oracle Health Sciences InForm to enable automated, bi-directional and real-time information flow between the systems. The integration helps improve data integrity across the enterprise and virtually eliminates the need to rekey data.
· “As the industry’s only true end-to-end data management solution, Oracle Health Sciences Data Management Workbench enables health sciences organizations to improve clinical program productivity and reduce costs and risk by reducing study cycle times, improving data quality and decision making,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences.