Global Clinical Data Monitoring (GCDM )
The Situation Today
Clinical trials are becoming more complex and even more expensive than before. Here’s why:
There are currently 159,814 active trials being conducted in 185 countries with 32,058 studies recruiting subjects.
The average cost per patient for a Phase III trial is more than USD 26k and the average cost of a complex trial is USD 100mn, elevating the average cost of a drug to around USD 4bn.
Traditionally, clinical trials relied heavily on onsite monitoring approaches and included significant amounts of source data verification (SDV) to help ensure subject safety and generate quality data. However, the current practices are expensive and do not guarantee quality.
Onsite monitoring cannot detect data fraud.
Monitoring is a significant cost driver with 30% of the budget in large global trials being spent on site monitoring.
Onsite monitoring/source data verification (SDV) queries only found 2% of critical data issues and 7.5% of overall data issues.
How HCL Can Help
HCL’s GCDM solution provides a flexible and risk balanced approach to monitoring, by combining centralized and adaptive monitoring methods.
Centralized monitoring: The data collected from labs, electronic data capture (EDC), clinical trial management systems (CTMS), electronic trial master files (ETMF), randomization and trial supply management (RTSM) is monitored centrally by a team of hybrid-skilled data management and analytics personnel. They detect errors in critical data variables, address issues and analyze the trends in lab data.
Adaptive monitoring: Real time data from centralized monitoring provides continuous performance metrics, giving operational teams the visibility into how each site is performing, and allowing for scheduled site visits based on site performance and study requirements. It allows for dynamic resource allocation to all monitoring activities.
GCDM combines best-of-breed partner products in data transformation, clinical data repository (CDR), and monitoring together with HCL’s integration, data standards, and analytics services.
What You Can Expect
- Reduction in query resolution time
- Reduction in the number of protocol deviations
- Identification of unusual data trends
- Ability to focus on critical study parameters
Trial execution time savings
- Continuous site performance improvement measures
- Ability to focus on recruitment strategies
- Reduction in the number of subject withdrawals
- 40-45% savings in overall monitoring costs
- Permits onsite monitors to address critical study parameters, training needs, and strategic issues
- Effective utilization of monitoring resources
For more information, write to us at: email@example.com