caBIG Clinical Trials Suite

The caBIG Clinical Trials Suite (CCTS) is an enterprise clinical trials system being designed primarily for use in trial sites. The suite is comprised of a collection of interoperable modules covering a broad range of key areas in cancer clinical trials management.  These include:

  • Patient registration via the Cancer Central Clinical Participant Registry (C3PR)
  • Patient scheduling via the Patient Study Calendar (PSC)
  • Adverse events reporting via the Cancer Adverse Events Reporting System (caAERS)
  • Lab analysis via LabViewer
  • Clinical data management via C3D

Integration between these applications is centered around five key scenarios: Study Creation, Register Subject, Load Labs in CDMS, Lab-driven AE Creation, and AE-Triggered Schedule Change.  SemanticBits plays the key roles of Program Management and Enterprise Architect in this highly visible project.

Program Management

Projects deliver outputs, and programs create outcomes. We coordinated the subprojects within CCTS to exploit economies of scale and to reduce coordination costs and risks. Our primary was on long term improvement and organizing the components such that they meet the overarching concerns of the enterprise. We worked closely with our client to design strategies for long term benefits and improved capabilities and then directed the project teams to implement those strategies. SemanticBits effectively provided a layer above the management of projects that focused on selecting the best group of projects, defining them in terms of their objectives, and providing an environment where they could be run successfully.

Enterprise Architect

Primarily, the CCTS architecture aspires to promote interoperability to a broad range of Clinical Trials software by providing a robust implementation platform to share semantically annotated data set. SemanticBits personnel were responsible for defining this architecture in terms of the overall goals of the enterprise rather than any specific underlying projects. We leveraged open standards to provide facades and interfaces to individual components while retaining the overarching vision of how the enterprise should function. We used an Enterprise Service Buss called ServiceMix for message acceptance, transformation, translation, routing, and message delivery and the JBI component, for the development of several services. This allowed us to seamlessly make multiple applications integrated and interoperable. Furthermore, we applied a Service Oriented Architecture (SOA) not for the sake of leveraging specific technologies or concepts but with a specific design goal in mind to integrate existing and new systems in the most efficient, maintainable manner possible. Keeping this in mind, we selected from a set of technologies that we have built a deep expertise on, including web services, grid service, Enterprise JavaBeans (EJBs), RESTful services, and other technologies.