Imaging Biomarker Data Regulatory Compliance And

Under FDA's strict 21 CFR Part 11 [21] guidelines, new drug submissions must be supported by documentation that is compliant with all regulations. As explained above and illustrated in Figure 3, IBM's SCORE software asset has been designed for this purpose. SCORE's flexibility and modular design make it particularly suitable for the management of imaging biomarker data.

The FDA requires reproducibility of imaging findings so that an independent reviewer can make the same conclusion or derive the same computed measurements as that of a radiologist included in a submission. As a result, a unified architecture is required for a DICOM- based imaging data manage ment platform that supports heterogeneous image capture environments and modalities and allows Web-based access to independent reviewers. Automated markups and computations are recommended to promote reproducibility, but manual segmentation or annotations are often needed to compute the imaging findings. A common vocabulary is also needed for the radiological reports that spell out the diagnosis and other detailed findings as well as for the specification of the imaging protocols. Figure 7 shows how imaging biomarker data and work flows can be managed in a regulated multistakeholder environment. The solution includes a range of capabilities and services:

• Image repository: stores the image content and associated metadata.

• Collaboration layer: provides image life-cycle tasks shared across sponsors, CROs, and investigator sites.

• Image services: provide functionality such as security and auditing.

• Integration layer: provides solutions for integration and interoperability with other applications and systems.

• Image taxonomy definition: develops image data models, including naming, attributes, ontologies, values, and relationships.

• Image storage policy definition: defines and helps to manage policies and systems for image storage and retention.

• Regulatory interpretation: assists interpretation of regulations and guidelines for what is required for compliance.

• Portal: provides a role-based and personalized user interface.

In addition, the solution design incorporates the customized design, implementation, and monitoring of image management processes. It should also be pointed out that the medical image management solution architecture is fully based on principles of service-oriented architecture (SOA [22]). SOA is taking application integration to a new level. To take full advantage of the principles of SOA, it is important to start with a full understanding of business processes to be supported by an IT solution. Such a solution must be architected to support the documented business processes. The component business modeling (CBM [23]) methodology identifies the basic building blocks of a given business, leading to insights that will help overcome most business challenges. CBM allows analysis from multiple perspectives—and the intersection of those views offers improved insights for decision making. In the case of biomarker-enabled R&D, CBM will break down the transformed processes and identify the respective roles of in-house biopharmaceutical R&D functions and outside partners such as CROs, imaging core labs, investigator sites, genotyping services, and possible academic or biotech research collaborators.

After mapping work flows it is then possible to define a five - level service -oriented IT Architecture that supports the processes and work flows:

1. Discrete: hard-coded application

2. Partial: cross line of business processes

3. Enterprise: cross-enterprise business processes

4. Partner: a known partner

5. Dynamic Partner: any trusted partner

In its most advanced form, SOA will support a complex environment with integrated data sources, integrated applications, and a dynamic network of partners.

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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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