Academic Medical Research Centers

Accelerating translational research

The Clinical Translational Science Awards (CTSA) have made funding for academic medical research increasingly dependent on the ability to establish a reliable and scalable infrastructure to support translational research initiatives and to create an environment that can deliver on the promise of personalized medicine. A core infrastructure component is a clinical data repository (CDR) that has the ability to manage patient data in a secure central location that can link electronic clinical information from Electronic Medical Records (EMRs) and claims data with Laboratory Information Management System (LIMS) applications, tissue banks, Clinical Trail Management Systems (CTMS)/Electronic Data Capture (EDC) tools, omics assays, and scientific analysis tools. Putting a CDR into place includes not only technical challenges but also the critical needs to establish the appropriate data governance, patient privacy, modifications to Institutional Review Board (IRB) processes and consent policies around the collection and use of samples and data.

Recombinant By Deloitte can help Academic Medical Research Centers accelerate their research by offering the tools and services needed to build out a effective research infrastructure. Our solutions focus on leveraging existing staff, resources and available commercial and open source tools. Because Recombinant By Deloitte was founded as a result of a long collaboration with Partners Healthcare, a leading Academic Medical Research Center, we continue to work towards a vision to make the translation of medicine from the bench to the bedside an easier and more effective process.

Our solution for AMRCs includes the following offerings:

• Development of strategic roadmaps for implementing a research infrastructure
• Data governance/privacy strategy and design
• Research data warehouse development and management
• Integration of the clinical research data warehouse to identified systems to streamline research workflows (eIRB, tissue bank, CTMS/EDC, EMRs)
• Commercial support and implementation services for open source clinical research application frameworks
• Custom software or registry development for specific research focused projects

The transition to Personalized Medicine will require a number of components to be established at institutions. A clinical data warehouse will be a fundamental component of both research and clinical operations.

Health Insurance Portability and Accountability Act (HIPAA) and IRB requirements establish a virtual wall that controls the flow of data for research. An overall research infrastructure includes components and integrations to determine that the security wall protects patient privacy while still allowing for efficient access to data.

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i2b2 (Informatics for Integrating Biology and the Bedside)

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