As the world’s largest academic clinical research organization, the client combines the clinical expertise and academic leadership of a premier teaching hospital with the full-service operational capabilities of a major contract research organization (CRO). With nearly 1,000 faculty and staff, the organization is able to conduct any clinical research project, from a small pilot study to international megatrials. End clients of the organization include pharmaceutical and medical device makers, biotech companies, and government agencies. The clinical research organization’s mission is to improve the practice of medicine. The effects of this mission on patient care and on the state of medicine are felt globally.
The client approached Perficient seeking to develop an application for one of its services: the clinical events classification (CEC) group. The CEC group performs clinical trial event adjudication—which is the assessment of clinical trial patient events or outcomes—as a key element in providing clinical trial endpoint data. Specifically, the CEC group works with sponsors and clinical leadership during all phases of a clinical trial to design and execute the clinical trial event adjudication effort. To date, the CEC group has adjudicated over 100,000 events that involved nearly 200,000 patients.
In order to provide adjudicated endpoint data on a timely basis throughout a trial, the CEC group relies on integrated CEC and data management processes. Despite having a tracking system for some of the ancillary pieces, documentation was almost entirely paper-based. Documents were reviewed by hand, then printed and shipped to various locations worldwide. The client needed a solution that would track and manage this documentation, streamline the business process, and help with compliance and reporting.
Business Value Delivered
Perficient follows a proven, comprehensive strategic business consulting approach to envisioning and planning SharePoint solutions which leverages Perficient's experience and best practices. Perficient defines and validates client expectations and business requirements for the SharePoint solution. Following the successful strategy engagement, the organization then selected Perficient to define, build, and deploy an Electronic Clinical Events Classification (eCEC) system, a highly complex enterprise application, on the SharePoint platform.
The client chose the SharePoint platform for its workflow management, document management, auditing, and reporting and analytics capabilities. These foundational capabilities would help the client to manage critical clinical processes relating to Medical Imaging, Clinical Events Classification (CEC), and Trial Master File management.
Perficient worked collaboratively with the client at the initiation of its overall SharePoint program to help establish a vision for extending SharePoint, examining how SharePoint could and should be used to meet business needs. Perficient then helped to develop a roadmap for deployment that involved training, governance, and custom development including:
- Development of a long-term vision, strategy, and roadmap for deploying SharePoint.
- Definition of the physical and logical hardware requirements that support the vision.
- Development of a governance plan and framework to support the platform.
- Development of a specific data governance plan that aids the client in leveraging out-of-the-box SharePoint tools to rationalize terms and develop a taxonomy that will be used by the entire organization.
- Development of a training plan and training delivery for support personnel, developers, and end-users.
- Development of custom capabilities for the Clinical Events Classification group and Medical Imaging group that support specific business requirements.
Perficient and the client are pushing the limits of SharePoint, extending what it can do and how it can provide business and functional value across the organization. Building upon the base SharePoint platform, Perficient worked with the client to construct applications and processes specific to the business functions of the organization's intranet, extranet, and internet. Perficient not only worked with the client to develop the vision and strategy but also assisted in building a comprehensive solution that leverages the SharePoint platform and allows the organization to progress toward its forward thinking vision.
To manage the clinical business processes, the client leveraged both out-of-the-box and custom developed SharePoint components. Key components of the SharePoint solution include:
- Workflow that reduces paper and manual processes while increasing process efficiency and throughput.
- Integration to internal and external clinical systems.
- Permissions and security that integrate to existing systems such as Active Directory.
- Logging and event history that support compliance and customer reporting based on the FDA’s rigorous 21 CFR Part 11.
- Document management supporting version control and user access throughout business processes.
- Integrated dashboards and reporting that support business processes and proactive user interaction.
- Internal (intranet) and external (extranet and internet) customer support.
Launched at the end of 2011, the SharePoint solution proved to be transformational, both internally and externally. The clinical research organization demonstrated market differentiation in the clinical trial management industry. The Clinical Events Classification application is the first automated system of its kind and offers capabilities not yet seen in the market. Because of the application, the client will win more business and reduce sales cycle times. The process management capabilities offered by the CEC solution help the organization to deliver its services more efficiently, allowing the client to price competitively while offering customers real time access to data and interaction within the workflows.
Another market differentiator for the client is improved compliance and reporting. As a result of the application integrations, the client is now able to offer customers a robust compliance solution that is electronically based. The client benefits from flexible integration to customer clinical systems. Integration is facilitated through the use of flexible XML standards that allow for the quick development of complex system integrations related to medical data. With business critical processes now captured, automated, and standardized, efficiency has increased and errors have decreased; the costs associated with paper, printing, and shipping are also lower.
The client continues to look to Perficient to identify ways to further leverage and extend the SharePoint platform. Moving forward, Perficient will work with the CEC group, as well as other areas of clinical research trials, such as Medical Imaging and Site Start-Up, to streamline processes and enable technology relating to the different client services.