Oracle Introduces Oracle® Clinical Data Repository

DRUG INFORMATION ASSOCIATION (DIA) ANNUAL EUROMEETING, London, March 6, 2006 – Oracle today introduced Oracle® Clinical Data Repository, a solution that will help life sciences organizations make better decisions based on more accurate and timely information, which, in turn, can accelerate the introduction of new products, enhance productivity, manage compliance and reduce risk. Oracle Clinical Data Repository supports the mission-critical task of integrating clinical data from multiple sources and provides a repository for the integration and reporting of clinical and non-clinical data that enables regulatory compliance.

Simplifying the Integration Challenge

In order to effectively manage their clinical development portfolios and individual projects, life sciences organizations must constantly monitor regulatory compliance activities and have access to information from a variety of systems, including trial management, pharmacokinetic/pharmacodynamic (PK/PD), electronic data capture (EDC), clinical patient data, central lab and pharmacovigilance systems. Many companies have implemented complex and costly integration projects that attempt to pull data from these multiple systems into a single warehouse. Because of the complexity of maintaining the transformations and interdependencies of the underlying data, these efforts often result in an unmanageable set of point-to-point solutions with very little infrastructure or documentation supporting the critical central repository. The task of publishing content for the clinical research community only adds to the complexity.

"Oracle Clinical Data Repository will help life sciences organizations surmount integration challenges by providing a solution that manages all aspects of the integration process – data access, transformation, persistence and distribution – in a compliant framework," said Mychelle Mowry, vice president for Global Health Industries at Oracle. "It will also help them to streamline regulatory compliance. The regulatory drive toward adoption of standards, such as CDISC, will compel life sciences organizations to standardize the way they manage their clinical data, as well as how they format and structure the data for submission to regulators around the world. Oracle Clinical Data Repository will enable organizations to address these requirements by providing a controlled, structured environment in which to build and store clinical information in a ready-to-submit format."

Oracle Clinical Data Repository is designed to receive and present data using current and future data exchange standards. This capability will enable organizations to build tools on today's established standards while providing a platform to leverage emerging standards.

End-to-end Support and Workflow

Oracle Clinical Data Repository provides end-to-end support for integrating data from various clinical sources and, more importantly, provides the ability to manage the complete workflow process across the entire development organization, which includes defining the data repository structure; developing and validating the programs that analyze and report the data; and controlling access to the data, as well as the resulting reports and visualizations. All data objects are fully audited and version controlled in Oracle Clinical Data Repository, providing complete traceability from the data source, through the transformation process, and to the data and reports themselves.

The new product is designed for effectiveness and efficiency in development and use by providing "natural" environments for two distinct communities: developers, who define re-usable components, such as data integration transformations and standard report sets; and clinical researchers, who employ the components created by the developers to effectively manage their clinical research activities. Oracle Clinical Data Repository provides a single program development environment for developers and intuitive browsing tools for clinical researchers, all within a native Web environment. Its role-based security features help ensure that users see only the data appropriate for their security access.

Boehringer Ingelheim Begins Oracle Clinical Data Repository Implementation

Boehringer Ingelheim, which is among the world's leading pharmaceutical companies, has worked closely with Oracle on the development of Oracle Clinical Data Repository. Boehringer Ingelheim Medical Data Services was seeking an integration solution that would enable it to accelerate reporting, streamline regulatory compliance through the creation of audit trails and enhance productivity through faster access to critical data. Boehringer Ingelheim also wanted to improve analytical capabilities, which could help its researchers rapidly assess the viability of new compounds and accelerate the development of new products.

"We believe that Oracle Clinical Data Repository will provide a core platform that will not only help us improve productivity, but will also prepare us to fundamentally transform the way we develop drugs," said Klaus Stern, vice president Medical Data Services, Boehringer Ingelheim GmbH. "The process of collecting and analyzing data in clinical trials has essentially remained static over the last 20 years. With Oracle Clinical Data Repository, Boehringer Ingelheim will be well placed to embrace new data standards, such as CDISC, and to extract hidden value from our data."

Over several years, Boehringer Ingelheim had defined global standard metadata structures across the organization to enable rapid study set up and the production of standard datasets for statistical analysis. However, converting raw datasets to a collection of tables and listings ready for publication as part of a regulatory submission remained a highly complex and time-consuming process. In order to prepare the tables and listings, a biostatistician must define, write and execute a number of programs that transform, derive, aggregate, analyze and format the data. In addition, the ability to aggregate and visualize data remains restricted to specialists, so a researcher looking to retrieve information on a patient, for example, must request a specialized report – a process that requires significant time and resources.

"We wanted to accelerate and optimize our reporting process by building a standard library of components that could be combined and reused to improve productivity and visibility. In addition, we looked to streamline compliance by creating an audit trail of all programs," said Stern.

After beginning work on developing an integration solution in house, the company came to understand the many complexities of the endeavor and began to work with Oracle to realize the vision of the Oracle Clinical Data Repository. The need for support and product continuity moving forward also factored into Boehringer Ingelheim's decision to work with Oracle as opposed to developing a solution in house. The researched-based pharmaceutical manufacturer has begun the process of installing Oracle Clinical Data Repository across its global operations and will phase into production over the next year.

Ease of Use a Priority

Oracle Clinical Data Repository can help organizations streamline critical tasks that have historically taken up the valuable time of scientists and highly skilled informatics personnel. It is designed to help life sciences organizations simplify tasks around the management of clinical data and reduce the effort and uncertainty around the validation of processes. As a result, clinical researchers can focus on the interpretation of data rather than on its compilation, and informatics teams can direct their attention to the development of value-add tools instead of report creation.

Availability

Oracle Clinical Data Repository is scheduled to be available later this calendar year.