Electronic Common Technical Document

Figure 4 Health care and life sciences standards organizations.

SCORE Portal (JSR 168)

Cross-Trial Query



Trial Design Applications

Application Services Image Management and Analysis, External Data and Text Search


Application Services Image Management and Analysis, External Data and Text Search

InsightLink Middleware

Data Abstraction

Information Integration and Federation

Information Integration and Federation

Imaging Data

Genomic and Analysis Data Files

External Data

Figure 5 Proposed IT architecture for biomarker-based clinical development. (From Terry McCormick, Kathleen Martin, and M. Hehenberger, IBM Institute for Business Value, The evolving role of biomarkers: focusing on patients from research to clinical practice, July 2007, http://www.ibm.com/industries/healthcare/doc/jsp/resource/ insight/ .)

At the bottom data layer, summarized clinical submission data in CDISC's SDTM format receive feeds from a clinical data management system that stores case report forms. First, the associated metadata for the SDTM submission (such as the vocabularies used for the adverse event codes, lab codes, etc.) are mapped into the tables of the Janus data model. An extract-transform-load tool is then used to improve the scalability and data validation, cleansing, and transformation needed to load the SDTM data into Janus. One may also need to build a collection of applications and use-case specific data-marts on top of Janus. These can be designed using Star-Schema-based dimensional models for optimal query performance. In addition to the clinical submission data in Janus, one would need to establish links to the imaging data that often reside in picture archiving and communications Systems. After extraction, the images can be managed centrally using a standardized imaging broker service (such as provided by IBM's content management offering) and stored along with genomic raw and analysis files in a content management repository supported by IBM's Solution for Compliance in a Regulated Environment (SCORE [13]). Finally, external reference databases such as PubMed, GenBank, dbSNP, and SwissProt are integrated using unstructured information management technology provided, for example, by IBM's WebSphere Information Server/OmniFind middleware. All these content stores can be searched dynamically using a federated warehouse that uses a wrapper-based technology for linking diverse data sources. On top of the federation layer, we propose a data abstraction and query layer powered by the Data Discovery Query Builder (DDQB). DDQB has been designed to expose a user-centric logical data model (based on XML) mapped on top of the physical data model.

To support processes and workflows that may include the transfer of clinical biomarker data between pharmas, contract research organizations (CROs), imaging core labs, investigator sites (often academic medical research centers) and ultimately the FDA, the IT architecture should be designed as a service-oriented architecture (SOA). IBM's SCORE architecture satisfies this requirement and can therefore serve as a basis for the enablement of biomarker-based R & D.

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Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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