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Bioclinica SMART
Project Type
Clinical Trials, Imaging, Data Management, Software
Date
Feb 2015 to Dec 2018
The Problem: A large, recently merged organization with disparate technologies across various functional and therapeutic areas within clinical imaging and biomarkers (over 30 platforms and tools)
The Solution: a microservice-based SaaS framework, integrating proprietary and COTS software applications within a single, functionally-oriented platform, with web API support for third party data transfer
SMART – an End-to-End Solution:
Submit: A secure web and mobile portal for submission of image and non-image data for clinical sites, real-time query resolution, site qualification and setup, training, with over 6,000 users.
Manage: Unified a broad variety of functional areas within a common interface, related to the processing and management of received data, user, client, and equipment, study setup and medical device inventory, project configuration.
Analyze: Flexible toolset for advanced imaging operations, machine learning classification algorithms for image analysis, and semi-automated protocol design.
Report: Enterprise data warehouse and business intelligence engine, providing near real-time metrics, KPIs, and analytics to internal and external customers. ML-enhanced adverse event reporting.
Transfer: web transfer of client image and non-image data, automated data cleaning. Web API supports third-party integration for two-way transfer.
My Role in the Project:
I was the Lead Product Manager from initial Vision and Scope to execution and release. I authored over 20,000 line item requirements 300 use cases, and 600 pages of design specifications, for SMART applications and services. I also created and administered the customer rollout, and all training content for SMART.
Metrics of Success:
- Adoption of web data submission rose from 46% to 89% of users in the first year
- Processing over 3 million high-resolution medical images (DICOM) per year (hundreds of TB per day)
- Consolidation of technology reducing development support costs by 32%, increasing utilization for capital expenditures for the company
