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Risk-Based Management

As the size, number, and complexity of clinical research trials grow, the standard approach to monitoring has become costly. Ensure the protocol is executed correctly and study data integrity is maintained while protecting the safety, rights, and well-being of your study participants with Lumenis™, our eSource Ecosystem, a suite of solutions that captures and integrates electronic data from sites, clinicians, and patients at its source. Our configurable technology helps you guide proper protocol execution and ensures accurate and timely data reporting and alerting across all your study sites.

KEY BENEFITS

Review Documents and Data Remotely

Lumenis works with your protocol to capture, validate, and deliver your study data and source documents in real time, enabling your study monitors and clinicians to implement remote and real-time targeted review. Have confidence your trial is running as planned and in compliance with the protocol, Good Clinical Practice (GCP), and relevant regulatory requirements.

Detect Issues Earlier

Dynamic triggers at the point of care reduce protocol execution errors, allowing the site to correct and clarify potential issues during the patient visit. Mitigate risk and make critical decisions quickly and confidently with targeted source data review (TSDR). Our TSDR allows you to manage your clinical trial data using a risk-based approach grounded in the principles of TransCelerate and the Risk Assessment and Categorization Tool (RACT). Review only the data that is flagged using pre-determined criteria from your protocol and specified using Clinical Ink’s targeted-review functionality.

Save Time and Resources

Reduce the effort expended on low-value activities and focus your centralized/remote monitoring and targeted on-site monitoring activities with a complete view of your trial. Unlike systems that require transcription of data into EDC, Lumenis is integrated, capturing data directly at its source. Gain access to clinically validated data anytime, anywhere, saving your team time, travel, and money. Nearly eliminate non-value-added activities for clinical trial monitors, such as source document verification.

Collaborate Cross-Functionally

Take a more collaborative, cross-functional, team approach to your study. Monitors, data managers, third-party adjudicators, and other custom roles can be defined to allow multiple review types. Key monitor roles can even perform customized review assessments to ensure consistency in monitoring the most critical data. Lumenis supports increased data quality, patient safety, and efficiency because the data is complete and accurate when entered in the first place — everyone on your team can view the same information at the same time.

A CLOSER LOOK

Clinical Ink’s Lumenis eSource Ecosystem supports three specific approaches for sponsors’ risk-based monitoring strategies. These include:

Targeted Monitoring

Not all data is equal. Pre-defined triggers identify possible data integrity and protocol compliance issues based on patient-specific responses. Real-time data capture allows monitors to take action immediately — not days or weeks later. Structured adjudication review questionnaires ensure consistency in evaluating inclusion/exclusion criteria or particularly sensitive endpoints.

Patient Compliance

The Lumenis platform provides both detailed and summary tracking for percentage complete by patients, with respect to all of their assigned tasks. These tasks are part of your patient engagement strategy and improve questionnaire compliance as well as medication and visit adherence. Monitor the task completion rate and immediately identify patients who might be at risk in these categories.

Questionnaire Compliance Monitoring and Alerting

Sponsors and study teams are able to monitor the overall study and/or site compliance data as well as patient-specific metrics. By issuing summary alerts, our ePRO solutions ensure sites and study teams are informed, in real time, of specific conditions reported by patients. These alerts provide information regarding at-risk responses provided by patients within questionnaires, which may require site and study team follow-up.

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