overview
Challenges
- Delayed Patient Enrollment: Traditional processes slowed down patient identification and recruitment, impacting trial timelines.
- Data Fragmentation: Disparate data sources across multiple trial sites hindered comprehensive data analysis.
- Regulatory Complexity: Ensuring data compliance and generating FDA-ready datasets required meticulous data standardization.
- Manual Processes: High dependency on manual workflows led to inefficiencies and increased error rates.
Key Focus Areas
Accelerating patient identification, recruitment, and clinical trial processes using realtime data from devices and EMR applications
Aggregating data from disparate sources (EMR, medical devices, administrative databases) across 100+ clinical trial sites
Standardizing data through coding protocols for comprehensive analysis and interpretation
Solution Approach
- Cloud-Based Analytical Platform: Developed a scalable data platform with deployable connectors and a one-click deployment strategy, reducing site onboarding time to less than a week.
- Customizable Clinical Trial Setup: Enabled site-specific protocols and workflows for seamless integration.AI-Driven Patient Identification: Implemented clinical decision support tools to identify eligible patients quickly.
- Automated Enrollment Alerts: Integrated alert systems for site coordinators to streamline patient enrollment.
- Digitized Consent Process: Introduced digital consent forms with decision support, integrated with EMR, ensuring informed patient consent.
- Real-Time Monitoring Tools: Built-in Clinical Quality Dashboard, Data Explorer, and Visualizations for continuous trial oversight.
- Adverse Event & Outcome Tracking: Monitored adverse events, treatment efficacy, and patient outcomes, including survival rates and treatment responses.AI-Powered Data Enrichment: Leveraged NLP and NER techniques to enhance data quality and aggregate clinical notes.
- Stakeholder Dashboards: Provided real-time dashboards for sponsors and site investigators to track trial progress.
Results & Impact
50% automation of manual clinical trial processes60% reduction in site onboarding time40% faster patient enrollment ensuring timely access to investigational drugs
Regulatory success with FDA-ready datasets enabling smooth submission and drug approval
Improved consent rates through digital tools and EMR integration
Enhanced data quality with reduced errors and improved accuracy