The Data Monitoring Committee initiative addresses the limited and diminishing number of experienced/qualified Data Monitoring Committee (DMC) members. This initiative aims to develop a framework/toolkit for Sponsors to use to increase the population of people with sufficient skills to serve on a DMC.
- Enhanced skills and number of people capable of serving on DMC, benefiting both individuals desiring to serve on DMCs and sponsors searching for competent DMC members
- Provides greater supply and options for sponsors regarding potential DMC members
- Supports sponsor efficiency, data access / accuracy, patient safety and quality
- Enables the future state of monitoring and improves DMC reputation
The Protocol Deviations Initiative is striving for an improved protocol deviation processes that should ultimately lead to improved patient safety, reliability of study data, human subject’s protections and data quality.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring initiative seeks to develop a model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.
Quality Management System
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.