cdx software analysis automation


In Vitro Companion Diagnostics Automation Assessment


Perform a cross-functional system analysis to study the feasibility of automating the development process of in vitro companion diagnostic devices for multiple drug product lines, improving quality, mitigating risks, and providing a means for effective interfaces between statisticians, scientists, systems engineers, quality, regulatory, and other business stakeholders.

Produce a suitable software architecture including physical, logical, information, security, and technology viewpoints.


The company is a world class pharmaceutical leader developing personalized medicine that relies on companion diagnostic devices for safety and efficacy, involves a complicated regulatory review process for both the drug (CDER) and diagnostic device (CDRH) and can be challenging to successfully commercialize and keep within budget. The drug-diagnostic co-development with different vendors for biomarker identification, assay development, kit development, technology identification, multicenter clinical trials, regulatory submissions, accredited clinical laboratories, CDx software development, and finally registration and deployment. The coordination of tasks and timelines is complex and small delays during any of the tasks impact multiple vendors and affect more delays.

More, the development processes for the companion diagnostic devices are classified as Class III (high risk) and must meet the regulatory design controls standard with the highest level scrutiny. These activities are further challenged due to the multi-disciplinary IVD assay contributors, and the inherent complexities in technical communications for specifying fully the diagnostic software functionality. With multiple drug programs active at any time it is desired for standardizing the overall process to develop companion diagnostic devices with better efficiencies and more integrations.


Engaged with key stakeholders representing each stage in the CDx development life cycle (research & development, regulatory, deployment, operations, etc.) and representative proxies for health care/IT system users (physicians, lab partner companies, etc.). The information collected from the subject matter experts was then balanced to address the top program goals, overcome the identified challenges and obstacles, and derive an integrated solution. Based on the specific workflow and operational requirements gathered, an architecture was developed with emphasis on the identified target qualities, with a wizard like process flow that automated the complete CDx application development process. The architecture was based on meta-data and data abstractions that model the assay logical elements; including provisions for built in safety features that validate the processing environment (PC), perform sanity checks on the input data, verify consistencies within the assay analysis logic and output generated, and secure access to sensitive IP and patient data (analysis algorithms, HIPAA/ePHI requirements, etc.)

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