Clinical Trial Team Structure Strategies
Demands of industry and regulators for an improved clinical research landscape include quality by design concepts and increased efficiencies. Teams developing clinical research trials must be strategic to meet these demands and discover future innovations. Team structure must adapt to successfully implement a risk-based approach to trial execution. Team structures should become flexible and collaborative.
Additional roles must be included on a Sponsor/CRO trial team including Centralized Monitors and Data Analysts to improve trial design and create opportunities for responsibilities to be shared across an increased range of specializations. Additional skill sets contribute to the team’s ability to develop and execute risk assessment categorization and a risk management plan. These innovative strategies require dedicated participation and input from an expanded trial team including, but not limited to these roles:
• Centralized Monitor
• Clinical Research Associate …show more content…
In the new team structure, expanded membership will share responsibilities to support the trial design process.
Early, collaborative development and documentation of risk evaluation and mitigation planning advance the study team’s abilities to reduce risk and streamline data review. Specifically, development of Key Risk Indicators and the Clinical Monitoring Plan require the expanded team structure to participate from initial stages of trial design. Early issue identification and well defined key risk indicators eventually lead to less time needed to review data. The quantity of data reviewed is reduced and the quality of data review is
Demands of industry and regulators for an improved clinical research landscape include quality by design concepts and increased efficiencies. Teams developing clinical research trials must be strategic to meet these demands and discover future innovations. Team structure must adapt to successfully implement a risk-based approach to trial execution. Team structures should become flexible and collaborative.
Additional roles must be included on a Sponsor/CRO trial team including Centralized Monitors and Data Analysts to improve trial design and create opportunities for responsibilities to be shared across an increased range of specializations. Additional skill sets contribute to the team’s ability to develop and execute risk assessment categorization and a risk management plan. These innovative strategies require dedicated participation and input from an expanded trial team including, but not limited to these roles:
• Centralized Monitor
• Clinical Research Associate …show more content…
In the new team structure, expanded membership will share responsibilities to support the trial design process.
Early, collaborative development and documentation of risk evaluation and mitigation planning advance the study team’s abilities to reduce risk and streamline data review. Specifically, development of Key Risk Indicators and the Clinical Monitoring Plan require the expanded team structure to participate from initial stages of trial design. Early issue identification and well defined key risk indicators eventually lead to less time needed to review data. The quantity of data reviewed is reduced and the quality of data review is