Deployment Scenario: ViewPoint® for Data Lifecycle Standardization
A large pharmaceutical company struggled with standardization of data terminology and supporting processes across multiple global sites. The company instituted a data lifecycle standardization initiative to provide global access, deployment and visibility for all clinical data standards.
The company’s immediate concern was that an estimated 40% of the organization was not aware of existing clinical data standards. A great deal of time and effort was being put into study start up activities that defined data standards for collection and analysis. To complicate matters, the standards being used were often not the most recently approved.
The company created a foundation for the data lifecycle effort by mandating the development, documentation and continuing use of Data Lifecycle Packages1. As a result of the implementation of this methodology, hundreds of users from multiple global sites required access to a library of data standards that were originally being stored in separate documents and spreadsheets on a shared file system. As standards were updated or changed, users required the ability to access the most current approved version of the standard. In addition, management needed visibility into what standards were being used across clinical programs and therapeutic areas.
The objective of the project was to provide real-time access to an approved library of data standards, thereby facilitating the deployment of organization-wide clinical data standards. Users also needed the ability to “package” current standards into study-specific collections that would facilitate study start-up activities such as database design and provide consistency across programs. Because data lifecycle packages address the entire clinical data lifecycle, they impact multiple cross-functional groups. This led to a requirement for a user-friendly software solution. Management also needed to obtain visibility into the use of specific data standards or variations to the standards in the context of individual studies, clinical programs and entire therapeutic areas. These requirements were predicated on the concepts of improved collaboration, minimizing rework and maximizing reuse for consistency whenever possible, with the ultimate objective of increasing quality and efficiency of clinical studies while decreasing time to study finalization by the clinical teams.
A cross-functional team was initiated to develop requirements and execute this project.
Viewpoint®, Octagon’s enterprise submission process management solution, was deployed as a central repository for data standards as well as the critical business information associated with the standards. The ViewPoint repository was segmented into three areas. A “Work Area” was created where data standards are accessed to support review and approval processes. Once approved, the data lifecycle package, which provides key information about a specific data standard (such as definition, description, use, sample wording for protocols, appropriate database structure, etc.) is added to the “Library Area”. This area holds all approved standards and is accessible to all global users of the system. A third area in the repository, the “Study Area”, was identified for study specific standards to be collected, stored and retrieved by relevant database personnel supporting a specific study.
ViewPoint’s Agent Automation Framework was developed and deployed to automatically concatenate a selected group of standards into one study standards package in MS WORD that is readily accessible and easily consumed by study personnel. This allows users to view and select the most recent and relevant standard and automatically generate a study-specific file that documents the standards chosen for a given study.
Extended attributes (metadata) about data lifecycle packages are entered into ViewPoint to track use scenarios for specific data standards. This critical business information is also used to provide visibility into the use of standards in the context of individual studies, a clinical study program or a therapeutic area. Additional information about what standards were used in a specific study was captured as ViewPoint attributes including study number, title, study characteristics, therapeutic area and an identifier as to whether it is an international study. Users can search across these attributes to understand when and where a standard is being used. This view offers an opportunity to reduce rework and maintain consistency when evaluating the use of a specific standard. More importantly, this also provides consistency with future studies of the same drug or therapeutic area and facilitates comparability of the studies when assembling the submission.
Global web-based and on-site training supported the successful rollout of the new system and processes. The full implementation of ViewPoint (including design, installation, implementation) required approximately two months.
Role-specific support for world-wide access, customized metadata fields and refined processes enabled a global pharmaceutical organization to find new efficiencies within their current business practices. By providing a central repository of approved data standards and capturing metadata throughout the process, the company was able to significantly decrease study start-up time, design and deploy data standards globally and provide process and data consistency across sites, studies and programs. The company now has the capability to run real-time reports on the use of specific data standards to support analysis and modification of the standards over time. An easy-to-use interface supports access to and navigation within and across the standards. The capabilities offered by ViewPoint enabled the organization to minimize rework within and across programs while also automating the aspects of the project that ensured success at a global level.
The value of the solution was found in the ongoing management and control of data standards, providing a mechanism for users to assess the time, quality and cost impact of using a standard. Decreased time required to set up a study using approved data standards, easier access to standards when reviewing set up decisions, user friendly reporting on use scenarios and visibility across the entire portfolio of studies and clinical programs were all added benefits of the increased visibility and control. Study set up time has been significantly reduced. Users have real-time access to most relevant and recent standards and management has visibility into and control over the deployment of individual standards.
To learn more about this project or how your organization can benefit from process visibility and control, contact Octagon at 610.535.6500 or visit our web site at www.octagonresearch.com.
1The term “Data Lifecycle Packages” is registered to Kestrel Consulting and describes a comprehensive methodology to standardize clinical data across the data lifecycle, from protocol development to clinical study reporting.
