AI-Powered Clinical Trial Optimization
— Service Area
Digital Health and Data Strategy
— Focus Area
- Clinical Data Management Optimization
- AI and Automation in Clinical Data
- Offshoring and Outsourcing Strategy
- Regulatory Compliance (CDISC, FDA, EMA)
— CLIENT
A leading professional services firm advising a global pharmaceutical company on optimizing its clinical trial data management strategy.
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— Challange
The client was supporting a large pharmaceutical company struggling with inefficient clinical data management workflows due to:
- High operational costs for in-house data management.
- Fragmented outsourcing strategy with multiple CROs and offshore vendors leading to inconsistencies in data quality.
- Regulatory compliance concerns with CDISC standards, FDA, and EMA requirements.
- Lack of AI-driven automation, making data cleaning and validation time-consuming.
The client needed a comprehensive strategy to optimize clinical trial data workflows, offshoring models, and AI-driven automation, ensuring cost efficiency, compliance, and scalability.
— Approach
To address these challenges, we developed a data-driven transformation strategy with the following key steps:
- Data Management Operating Model Optimization
- Assessed current-state clinical data workflows to identify inefficiencies.
- Recommended a centralized governance model to ensure consistency across outsourced vendors.
- Developed a hybrid outsourcing model, balancing in-house expertise with offshore data management teams (India, Eastern Europe, Latin America).
- AI-Driven Automation & Process Optimization
- Identified AI-driven solutions for data cleaning, medical coding (MedDRA, WHODrug), and anomaly detection.
- Suggested implementation of machine learning models for automated discrepancy detection and predictive query management.
- Advised on integrating real-world data (RWD) sources into clinical trial datasets for enhanced trial insights.
- Regulatory Compliance & Data Standardization
- Mapped data processes to CDISC SDTM and ADaM standards to ensure smooth FDA/EMA submissions.
- Recommended 21 CFR Part 11-compliant systems and processes for data integrity and audit readiness.
- Designed a vendor management framework for CRO oversight and regulatory alignment.
- Offshoring & CRO Strategy Optimization
- Conducted a cost-benefit analysis of offshore data management models.
- Recommended a shift towards a Functional Service Provider (FSP) model, ensuring dedicated offshore teams while maintaining sponsor oversight.
Evaluated leading CROs (IQVIA, ICON, Parexel, Syneos) to identify the best fit for the client’s needs.
— Expected Results
By implementing this strategy, the client can expect:
✅ 30-40% reduction in data management costs by optimizing offshore operations.
✅ Improved data quality & compliance, ensuring seamless CDISC, FDA, and EMA submissions.
✅ 50% faster query resolution through AI-driven automation.
✅ Stronger vendor governance, reducing data discrepancies and improving efficiency.
✅ Scalability for future trials, with a more structured clinical data management framework.
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