Study monitoring services
Appropriate monitoring throughout the project lifecycle is essential to ensure the integrity of your clinical trial. At ethica CRO, we offer both on-site and centralized study monitoring services, depending on the requirements and risks of your clinical trial. The implementation of risk management strategies as well as central and on-site monitoring services ensures that all data is collected in accordance with the study protocol and that the rights and safety of research participants are protected. The adoption of a comprehensive risk-based monitoring strategy allows for:
Earlier detection of issues, with emphasis on resolution and prevention of issue recurrence
Focus on study-specific critical data and processes
Reduction in efforts spent on low-value activities, leading to greater return on investment
Do you have the right risk management strategy for your clinical program?
Our Study Monitoring Services
At ethica CRO, we offer a holistic, risk-based study monitoring approach that combines the expertise of our Clinical Data Managers, Clinical Project Managers, and Clinical Research Associates. As such, our highly qualified study monitoring team is trained to identify data anomalies and make proactive decisions to minimize potential risks to your study.
- North American coverage
- Site qualification visits
- Site initiation visits
- Site interim monitoring visits
- Site close-out visits
- Risk-based monitoring assessment
- Data quality oversight
- Centralized statistical monitoring
- Triggered monitoring
- Remote monitoring
Our Clinical Study Monitoring Approach
Our Study Monitoring Procedures
During the study kick-off meeting, the critical data supporting the primary and secondary endpoints of your study will be confirmed, starting with the finalization of the Project Management Plan. This document outlines the appropriate processes to achieve the objectives of your trial while ensuring the safety and quality of your study. The Project Management Plan will give rise to all other essential study documents, such as the Monitoring Plan, Safety Management Plan, Data Management Plan, and Data Validation Plan.
The Clinical Project Manager and Associate Director of Clinical Research will work with you to determine the most suitable and cost-effective Monitoring Plan, which will lay out the rationale and extent of study monitoring, whether it be on-site, centralized, or a combination of both. The Data Management Plan and the Data Validation Plan will provide fully documented oversight of data quality and centralized monitoring processes.
Once your trial has begun, our team remotely tracks the progress of your study. Statistical analyses will be run by our Clinical Data Managers on a regular basis in order to identify data anomalies and potential protocol deviations. Pertinent issues are reported to our Clinical Project Managers, CRAs, and Directors who will ensure the implementation of appropriate corrective measures either by targeting on-site monitoring or resolving specific issues remotely, depending on the severity and nature of the concern.
Our risk-based study monitoring approach results in targeted, meaningful, and informed oversight activities. At ethica CRO, we guarantee that our study monitoring activities will lead to reduced risk of harm to research participants and more robust and meaningful research data.